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U.S. Department of Health and Human Services

Class 1 Device Recall ACCUCHECK PERFORMA STRIP

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  Class 1 Device Recall ACCUCHECK PERFORMA STRIP see related information
Date Initiated by Firm May 18, 2011
Date Posted June 21, 2011
Recall Status1 Terminated 3 on October 25, 2011
Recall Number Z-2570-2011
Recall Event ID 58896
Product Classification glucose monitoring test strips - Product Code NBW
Product ACCU-CHECK PERFORMA STRIP NO. 05987288031, 100 BANDELETTES REACTIVES, ROCHE DIAGNOSTICS GMBH, WWW.ACCUCHEK.COM glucose monitoring test strips.
Code Information Lot Number 470049, expiration date 12/31/2011.
Recalling Firm/
Manufacturer		 Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis IN 46256-1025
For Additional Information Contact Betsy Cox
317-521-3900
Manufacturer 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 2		 Component design/selection
Action 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
Quantity in Commerce 27,019 units
Distribution No US distribution, in France Only.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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