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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmJune 11, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on May 10, 2004
Recall NumberZ-0935-04
Recall Event ID 28909
510(K)NumberK955644 
Product Classification Enzyme Immunoassay, Carbamazepine - Product Code KLT
ProductSynchron Systems Drug Calibrator 1 (Carbamaxepine, Phenobarbitol, Phentoin, Theophylline, and Valproic Acid).
Code Information Lot M207140
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Product was found to produce higher recoveries by about 7-12% compared to other lots.
FDA Determined
Cause 2		Other
ActionUsers were requested to discard and ask for replacement of the lot in question by letter.
Quantity in Commerceunknown
DistributionNationwide and Canada
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = KLT
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