Bayer Contour TS blood glucose test strips packaged in packs of 10, 25, 50 and 100 strips; Bayer Healthcare, Mishawaka,

FDA device recall Z-0932-2008 · posted 2008-03-13 · Terminated

Recall details

Recalling firm

Bayer Healthcare LLC

Reason for recall

Inaccurate Test Strips Results: Results in blood glucose readings with a positive bias are outside the product specifications. Patient test results may demonstrative results 5 percent to 17 percent higher.

Action taken

The firm issued a Press Release on 12/21/07. A Test Strip Recall letter was also sent to the firm's consignees and health care providers instructing them that use of the product should cease and that health care providers contact the firm for replacements. Additional information can be found at www.bayerdiabeties.com or by contacting the Bayer at 1-800-348-8100.

Root cause

Process design

Status

Terminated

Product code

LFR

Quantity affected

97,000 bottles of test strips

Distribution

Worldwide Distribution --- including USA and countries of Austria, France, India, Korea, Mexico, Philippines and Turkey.

Date initiated

2007-12-21

Date posted

2008-03-13

Date terminated

2009-07-07

Location

Mishawaka, IN