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

FDA device recall Z-3268-2011 · posted 2011-09-19 · Terminated

Recall details

Recalling firm

Bayer Healthcare, LLC

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

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

LFR

Quantity affected

3,617,287 vials/ 54,555,460 test strips

Distribution

Nationwide Distribution and Puerto Rico

Date initiated

2011-08-12

Date posted

2011-09-19

Date terminated

2012-07-02

Location

Mishawaka, IN

Related 510(k) clearances