IMPORTANT: FREESTYLE AND FREESTYLE LITE MEDICAL DEVICE NOTIFICATION

Rita
By Rita Latest Reply 2011-03-15 08:50:47 -0500
Started 2009-03-27 14:19:27 -0500

I just received a letter from Abbott Diabetes Care so i tough i listed here.
Freesyle Test Strip Lot Numbers 0803221, 0802523, 0802832, 0802823, 0802422 and 0718730
and FreeStyle Lite Test Strip Lot Number 0817617, and 0812304.
Dear Valued Customer,
Recently, it has come to our attention that FreeStyle and FreeStyle Lite Test Strips from the eight (8) lot numbers mentioned above are being used by customers. These lots were not approved for distribution outside of Abbott Diabetes Care.
The six (6) FreeStyle Test Strip lots have the potential to generate an Error 3 ("Er3") message or fail to start a test while being used with a FreeStyle, FreeStyle Flash, FreeStyle Freedom or FreeStyle Navigator blood glucose meter and one (1) FreeStyle Lite Test Strip lot (lot 0812304) has the potential to generate the same error on FreeStyle Lite and FreeStyle Freedom LIte. Either situation will prevent the user from obtaining a blood glucose reading. Please know that any test results that have been received during prior tests while using these strips are accurate.
There is no evidence to suggest that the FreeStyle Lite test strip lot (lot 0817617) would cause an error or prevent the user from obtaining a blood glucose reading on a FreeStyle Lite or FreeStyle Freedom Lite blood glucose meter.
Please check the lot number on the test strip carton or vial to see if the strips are from one of the lot numbers mentioned above. Information is included on Page 2 of this letter that shows where to look for the test strip lot number. If the test strips are from an affected lot, please discontinue their use and call the Abbott Diabetes Care Customer Care line at: 1-800-310-1500. The ADC representative will provide information on how to return the test strips and arrange to have replacement test strips sent at no charge.
If you have any further questions, please call the Abbott Diabetes Care Customer Care line at 1-800-310-1500 so we can help you with your questions.
We sincerely apologize for any inconvenience this may cause and we thank you for your continued support of Abbott Diabetes Care and our FreeStyle and FreeStyle Lite blood glucose monitoring systems.
Sincerely,
Tina Mazurkiewicz
Division Vice President, Quality Assurance and Compliance
Abbott Diabetes Care


7 replies

Anonymous
Anonymous 2011-03-15 08:50:47 -0500 Report

We are having this same problem with a new lot 1078803. It either gives us a blank screen or an er3 reading and often takes four or five strips before a reading is determined. Has anyone else been having this problem? I can't afford to continue wasting expensive strips!

2009-03-27 19:16:22 -0500 Report

Thank you Rita. I use the freestyle lite test strips, and thank God, I don't have any of these lot numbers. I learned to keep my old bottles and they were all okay too. I didn't receive the letter from Abbott so if I did have them, I wouldn't have known! Thanks again, Angie

tmana
tmana 2009-03-27 18:23:08 -0500 Report

I received the same letter today.

Based on my occasionally saving labels or old test vials, I suspect the expiry dates on these lots should be somewhere around the second quarter of 2010, and if I had received any of these lots, it would have been about three months ago.

Regardless, this is much better than Lifescan's notification program, which sent recall letters out three months after they had been written, for strips that would have been in the market six months previously.

rbergman
rbergman 2009-03-27 15:00:58 -0500 Report

Thank you for sharing this information, both my daughter and I have freestyle lite meters and I checked our lot numbers and they are not on the list, I have a new pkg of 2 vials that we haven't opened yet but I went ahead and opened it just to make sure and they don't have these numbers either.

Thanks again for this information!
~Robin

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