Recall Z-2570-2011

Roche Diagnostics Operations, Inc. · initiated May 18, 2011

Terminated

Product

ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.

Codes / lots: Lot Number 470049, expiration date 12/31/2011.

Reason for recall

Erroneous results: Internal investigations revealed that the test strips exhibited a performance issue that can cause test strip errors or a bias in test result that exceed the tolerance range according to EN ISO 15197.

FDA-determined cause: Component design/selection

Action taken

Direct accounts were notified by a Roche Diagnostics press release on 5/18/2011 that included the product's name, lot number, and information to withdraw the remaining inventory of lot 470049 from storage

Details

Recall number
Z-2570-2011
Initiated
May 18, 2011
Posted by FDA
June 21, 2011
Terminated
October 25, 2011
Product code
NBW – System, Test, Blood Glucose, Over The Counter
Quantity
27,019 units
Distribution
No US distribution, in France Only.
Recalling firm
Roche Diagnostics Operations, Inc., Indianapolis, IN

Official FDA recall record