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U.S. Department of Health and Human Services

Class 1 Device Recall VeriCal Calibrator Set

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  Class 1 Device Recall VeriCal Calibrator Set see related information
Date Initiated by Firm August 19, 2005
Date Posted October 22, 2005
Recall Status1 Terminated 3 on October 16, 2006
Recall Number Z-0032-06
Recall Event ID 33440
Product Classification System, Multipurpose For In Vitro Coagulation Studies - Product Code JPA
Product VeriCal Calibrator Set
Code Information Lots 161813, 161907, 161908, 161909
Recalling Firm/
Manufacturer		 BIOMERIEUX, INC.
100 Rodolphe St
Durham NC 27712-9402
Manufacturer Reason
for Recall		 The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
FDA Determined
Cause 2		 Other
Action Consignees were notified on/about 08/31/2005.
Quantity in Commerce 2334 kits
Distribution Nationwide
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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