Certain lots of precision xtra, precision xceed pro, medisense optium, optium, optiumez and relion ultima blood glucose test strips may generate erroneously low blood glucose results. Fda announces recall of abbott glucose test strips strips sold in retail stores, online and used in health care facilities the u. However, you should confirm that the meter displays lot 45001 glucose test strips or code 75001 ketone test strips when a test strip is inserted. Abbott announces discovery of new strain of hiv, keeping global health community a step ahead of the virus. Description abbott precision xtra test strips box of 100ct. Important safety information omnipod insulin management system. No doubt any of you using omnipod systems regarding the fallibility of abbotts freestyle test strips in your pdm.
No coding precision xtra test strips no longer require use of a calibrator with each new box of test strips. Dec 02, 20 the abbott freestyle blood glucose test strip recall was announced by the fda on november 27, due to a risk that the test strips may provide erroneously low blood glucose results. To receive replacement strips at no cost contact abbott diabetes care customer service at 18775845159. Class 1 device recall freestyle flash blood glucose monitors. As of may 31, 2017 health canada has approved the use of both freestyle regular and freestyle lite strips for use with the omnipod pdm. Stock up on freestyle test strips to test blood glucose levels with the freestyle blood glucose monitoring system. Abbott freestyle test strips are used with the builtin freestyle meter for the.
The pdm glucose meter is intended for singlepatient use and should not be shared. Freestyle lite blood glucose test strips 100box for the omnipod insulin management system features. Abbott freestyle test strips are used with the builtin freestyle meter for the quantitative. Wirelessly programs the pod with your personalized insulindelivery.
Fda and abbott diabetes care are issuing a recall of 359 different lots of glucose test strips marketed under the following brand names. To receive replacement strips at no cost contact abbott diabetes care customer service at 1. Has a backlit color touchscreen for visibility in the dark. On february 19, abbott announced a recall of freestyle and freestyle flash blood glucose meters, which may produce low blood sugar results incorrectly when used with freestyle or freestyle lite blood glucose test strips e. For questions about the recall, please call the abbott diabetes care customer service at 0500 467 466. The recall for the abbott freestyle test strips was initially issued in november 20 and expanded to all versions of the abbott freestyle test strips in late january 2014. Abbott is making this new strain accessible to the research community to evaluate its impact to diagnostic testing, treatments and potential vaccines. Class 1 device recall freestyle flash blood glucose monitors fda. Flash glucose monitoring system with optional realtime alarms. Apparently theyre producing sufficiently inaccurate low readings to warrant a. Neither meter has been in production since 2010, and the recall of these two products will. Abbott test strips, abbott glucose strips emergency medical. Abbott diabetes care announces recall of certain lots of.
Works with blood sample the size of a pinhead easily samples from sites other than the fingertip. Need advice on omnipod and freestyle test strips self. Sample recognition testing designed to begin only when adequate sample is applied. The omnipod system revolutionized insulin management with its waterproof wearable pod, and simpletouse personal diabetes manager pdm. Abbott precision xtra test strips case of 12 x 50ct sale. Abbott continues glucose meter recall medpage today. Freestyle lite homeuse blood glucose test strips manufactured by abbott diabetes care 201209 the medicines and healthcare products regulatory agency mhra has asked people with diabetes to check if they have certain lot numbers of a specific type of blood glucose test strip, because a manufacturing fault in some of. Omnipod users can receive replacement strips at no cost by contacting abbott diabetes care customer service at 18775845159.
Abbott freestyle test strips are used with the builtin freestyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott laboratories recalls diabetes test strips product. Recall of certain lots of abbott freestyle glucose test strips. Food and drug administration today announced the agency is working with abbott diabetes care to recall 359 different lots of glucose test strips marketed under the following brand names. Innovative test strip design easier to apply blood. Regarding abbott freestyle flash, freestyle blood glucose. Blood glucose and ketone test strips freestyle blood. Freestyle lite blood glucose test strips freestyle.
A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels, or if hypoglycemia or impending hypoglycemia is reported but the symptoms do not match the system readings. Abbott laboratories recalls diabetes test strips product list. I use freestyle test strips because my omnipod pump controller doubles as a meter. The customers were instructed to read all of the materials included in the abbott communication carefully and make sure you understand how it affects you.
Abbott diabetes care produce different blood glucose test strips to suit your needs. No use of any abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of abbott laboratories, except to identify the product or services of the company. Urgent product recall notice to all known customers using the affected freestyle blood glucose meters. Mar 17, 2014 abbott advised omnipod patients to use alternate test strips and to watch for symptoms of high blood sugar. Abbott is dedicated to developing innovative products that make glucose testing easier and more accurate. For the omnipod personal diabetes manager pdm to receive replacement strips at no cost contact abbott diabetes care customer service at 18775845159. If you are using the freestyle blood glucose meter built into the omnipod personal diabetes manager pdm, you must discontinue use of any freestyle blood glucose test strips you may have until you obtain replacement strips from abbott diabetes care. Freestyle precision neo blood glucose test strips, 50 strips. Scott house 5107495400 manufacturer reason for recall. The omnipod dash system simplifies insulin management management for people with t1d or insulindependent t2d. Freestyle lite test strips omnipod program diabetes. The harpers named insulet, the maker of the omnipod, as a. Class 2 device recall omnipod insulin management product.
Freestyle blood glucose monitoring systems, lancing. I have an awesome for the most part mailorder pharmacy that dutifully ships me 300 test strips a month. Freestyle blood glucose test strips are the only strip type that is approved for use with your omnipod insulin management system. The strips are literally rd the price of the other major brands and they work just as well better than the strips i had trouble getting to go with my omnipod pdm. The recalled devices havent been in production since 2010, according to an fda memo. The abbott freestyle blood glucose test strip recall was announced by the fda on november 27, due to a risk that the test strips may provide erroneously low blood glucose results. Our systems and mobile apps offer a range of features to meet the specific needs of people living with diabetes1. Insulet corporation, the company behind omnipod insulin management system, announced it has signed a worldwide agreement with lifescan, inc. Recall regarding abbott freestyle flash, freestyle blood. Good omnipod experience but freestyle test strips are a ripoff. This product recall is only pertaining to freestyle.
Abbott announces voluntary recall of freestyle and. Easier, faster blood application and uptake reapplication time up to 60 seconds. In november 20, abbott recalled 20 lots of test strips for the freestyle meters due to the potential for. Scanning the sensor to obtain glucose values does not require lancets 2.
Dec 23, 2010 abbott laboratories recalls diabetes test strips product list. Discontinue use of your freestyle flash or freestyle blood glucose meter and call abbott diabetes care customer service at 18883455364. Glucose meters, and the freestyle meter built into the omnipod system. Compact, lightweight, and includes a builtin freestyle precision neo test strip port for blood glucose testing. Omnipod freestyle glucose recal issued due to erroneous. Abbott recalls older freestyle glucose monitoring systems. Abt issued a recall of its freestyle and freestyle flash blood glucose meters, warning that the devices may produce falsely low readings when paired with the freestyle test strips. Abbott said it will replace the affected test strips at no charge. Ive been buying target brand test strips to go with the cheap meter they sell. Its great because i dont have a carry yet another device to check my blood sugar. Programs the pod with your personalized insulindelivery instructions.
In recent press release, abbott states they are recalling the freestyle test strips and glucose meters. Abbott diabetes care and the united states food and drug administration fda announced a voluntary recall of the freestyle blood glucose test strips. The pdm is a wireless, handheld device that is used to program the omnipod with customized insulin delivery instructions, monitor the operation of the omnipod, and check blood glucose levels using freestyle blood glucose test strips. Urgent product recall notice to all known customers using the affected freestyle blood glucose meters built into the omnipod insulin management system with. Abbott freestyle test strip lawsuits wolf and pravato. Abbott freestyle test strips recall i am a type 1 diabetic. The recall extended further to users of insulets nsdq. Freestyle lite test strips omnipod program diabetes express. Abbott recalls blood glucose test strips massdevice. Abbott may modify or rescind this offer at any time without notice. This section will tell you a little more about the unique characteristics of each of them. Recall of abbott glucose test strips false low blood. Abbott diagnostics recalls blood glucose meters over false. Abbott recalls blood glucose meters over false readings.
Freestyle libre glucose monitoring system diabetes care. The faulty strips may produce erroneously low blood glucose results when used with a freestyle blood glucose meter built into the omnipod insulin management system. Apr 14, 2014 on march 14, abbott sent an important. There is no tubing connecting the omnipod to the pdm. Dec 02, 20 in 2010, abbott pulled 359 million test strips off the market in the u. Precision xtra blood glucose test strips for in vitro diagnostic use the precision xtra blood glucose test strips, designed with trumeasure technology, feature the following benefits.
Abbott laboratories recalled the test strips just four days after abbie harpers death. Product title relion prime blood glucose test strips, 100 ct average rating. No doubt any of you using omnipod systems regarding the fallibility of abbott s freestyle test strips in your pdm. An ideal choice for those who like to keep things simple, the pdm includes a built in blood glucose meter. The easytouse therasense test strips allow people with diabetes to take a blood sample from multiple sites including their fingertips, forearm, upper arm, thigh, calf and fleshy part of the hand, eliminating virtually all the pain of testing. Insulet to integrate lifescans onetouch into next generation. Abbott advised omnipod patients to use alternate test strips and to watch for symptoms of high blood sugar. Abbott test strips, abbott glucose strips emergency. Aug 31, 2011 fda announces recall of abbott glucose test strips strips sold in retail stores, online and used in health care facilities the u. Freestyle copilot software freestyle glucose meters.
Currently omnipod pdms use abbotts freesyle test strips. Abbott diabetes care will provide further information when you call on the process to obtain your test strips going forward. The freestyle libre flash glucose monitoring system is designed to liberate patients from the hassles1 of glucose monitoring. The defect is associated with test strips exposed to warm weather or prolonged storage and involves. It seems that abbott makes freestyle test strips and that they are the only strips that work with omnipod. Glucose readings with a painless 1 1 second scan even through clothing. Abbott has recalled 2 older blood glucose monitoring systems, freestyle flash and freestyle, and told omnipod users to stop using the builtin.
Abbott freestyle test strip recall issued due to false. Insulet corporation insulet or the company has initiated a. A small sensor automatically measures and continuously stores glucose readings day and night. Freestyle lite blood glucose test strips have been updated to incorporate the new zipwik tabs. Class 1 device recall abbott diabetes care, precision xtra. Good omnipod experience but freestyle test strips are a rip. Abbott labs sued over allegedly defective freestyle test. Using other brands of test strips and control solutions with the. For questions or concerns with the continued use of your mylife omnipod.
At the time, abbott laboratories waited two months to send out letters warning users of its freestyle test strips of the recall and danger of being given erroneously low. Food and drug administration said wednesday that abbott laboratories is recalling up to 359 million testing strips used by diabetics because they can give falsely low blood sugar readings. Abbott labs sued over allegedly defective freestyle test strips. Abbott has recalled 2 older blood glucose monitoring systems, freestyle flash and freestyle, and told omnipod users to stop using the builtin monitor until their current strips can be replaced. Omnipod insulin management system important safety information. What should i do if i, someone in my office or my patients continue to have questions. Abbott freestyle control solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly. Abbott is recommending that you discontinue use of the effected strips and meters immediately, and call for replacements. Insulet issues recall of omnipod insulin management system. Dec 22, 2010 fda announces recall of abbott glucose test strips strips sold in retail stores, online and used in health care facilities the u. Back in 2010, abbott pulled 359 million test strips from the market in the u. Diabetics using the omnipod system will be affected. Good omnipod experience but freestyle test strips are a. Podd omnipod systems with builtin freestyle blood glucose meters, abbott reported in a letter.