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
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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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