Class I Medical Device Recall: Roche Diagnostics Operations, ACCU-CHEK Performa Strip

Recall Class: Class I

Date Recall Initiated: May 18, 2011

Product: ACCU-CHEK Performa Strip, Lot #470049

This product was NOT distributed in the U.S. The product was only distributed in France on October 5, 2010.

Use: These test strips are used to monitor blood glucose levels.

Recalling Firm:

Roche Diagnostics Operations, Inc.

9115 Hague Road

Indianapolis, Indiana 46256-1025

Reason for Recall:

Errors may occur that may cause falsely-elevated blood glucose test results.

Public Contact: Director, Corporate Communications, 1-317-521-3911

FDA District: Detroit

FDA Comments:

On May 18, 2011, the firm announced the recall through a French press release. In addition to the information about the product, the firm informed its customers to withdraw the remaining inventory of this lot from storage.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s Safety Information and MedWatch Adverse Event Reporting Program [1] either online, by regular mail or by FAX.

SOURCE [2]