Statement from Bayer on Contour Strip Recall

I just received this statement form Bayer: 

BAYER HEALTHCARE RECALLS 10-COUNT and 25-COUNT VIALS OF BLOOD GLUCOSE TEST STRIPS IN UNITED STATES

US Action Follows Stop-Ship That Began in June


Tarrytown, NY --Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of this action.

These actions are not taken as a result of any adverse events reported to Bayer.  Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing. In the FDA’s view, this deviation from US-approved specifications constituted a technical violation that required a field corrective action under US regulations.

50-count vials of Contour test strips are not affected, and strips used with Bayer’s Breeze™2 blood glucose meters are not affected.

This action follows Bayer’s decision in late June to stop new shipments of products containing the small-count vials of these test strips world-wide.  And with no new shipments of small count vials into the market since that time, we believe remaining unused quantities of potentially affected product in the market are likely very small.

While it resolves this issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure continued, uninterrupted market access to unaffected strips.

Contact:

Susan Yarin
Bayer HealthCare
(914) 366-1738
susan.yarin@bayer.com

Possible Bayer Contour Test Strips Issue

Amy at Diabetes Mine tweeted information about Bayer test strips false low readings. She wrote:

Quality issue w/ BAYER CONTOUR TEST STRIPS 4 #diabetes - some batches create falsely low #bgnow readings cot.ag/qui8Mc

Thanks Amy for brining up the issue.

I wanted more than a tweets worth of information so I called Bayer communications team. There are some possible issues strips that come in cans that shipped with small strip counts. For example: the ten count cans that came with a  new meter.

This is my less than expert understanding: The issues apparently stems from shipping the low count cans and the amount of gas in the can vs strips. It seems the fewer strips and more gas can alter the chemistry of the strips slightly. This creates the possibility of reading slightly lower than they should. For you error grid fans (and there can't be anyone who is an error grid fan) Bayer told me the possible errors are in the non clinically significant error grid ranges.

My conjecture is that the issue also involves time in the cans before being opened as well but that is pure speculation on my part.

Bayer said they have stopped shipping the low count cans.

Bayer says the 50 count cans are OK. They suggest if you have any concerns to talk with you health care team or call their Bayer support number. That number as far as my search engine knows is 1-800-348-8100.

1) Don't stop testing.
2) If you have Bayer strips in cans that came with less than 50 strips call Bayer or your health care team.
3) See #1 above.