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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 Recall
ACCUCHECK PERFORMA STRIP
see related information
Date Posted June 21, 2011
Recall Status1 Terminated on October 25, 2011
Recall Number Z-2570-2011
Recall Event ID 58896
Product Classification System, Test, Blood Glucose, Over The Counter - 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, Indiana 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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