Z-3268-2011

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with...

Name: Z-3268-2011 Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with...
Creator: Bayer Healthcare, LLC
Published: 2011-08-12
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2011-08-12 / Terminated / root cause: packaging

FDA source

Bayer Healthcare, LLC began a recall of Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose... on 2011-08-12. The reason FDA records is "All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3268-2011
Status: Terminated
Initiated: 2011-08-12
Posted: 2011-09-19
Terminated: 2012-07-02
Recalling firm: Medrad, Inc.
Product: Contour, Contour TS Blood Glucose Test Strips and Bonus Packs Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
Product code: LFR Glucose Dehydrogenase, Glucose
Reason for recall: All 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled 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
Root cause tag: packaging
FDA root cause: Packaging
Action: Bayer sent an "URGENT DIABETES TEST STRIP RECALL" letter dated August 12, 2011, to its customers with the name of the test strips, sizes recalled, reason for the recall, potential injury, and instructions to discontinue use and return the test strips to Bayer. The recall letter also included a recall response form that was to be faxed back to Bayer at 1-800-876-2243. For questions call Customer Logistics at 1-800-348-2637.
Quantity in commerce: 3,617,287 vials/ 54,555,460 test strips
Distribution: Nationwide Distribution and Puerto Rico
Product codes and lots: 9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578. Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.

Product code LFR

K062058Class IIAscensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Bayer Healthcare / cleared 2006-09-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)