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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMay 20, 2003
Date PostedJuly 23, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall NumberZ-1148-04
Recall Event ID 28964
Product Classification Calibrator, Primary - Product Code JIS
ProductSynchron Systems Prealbumin Reagent Part Number: 475106
Code Information Lot M210125  Exp 30 Nov 04
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		Instability leading to falsely elevated patient results, out of range controls, or error code.
FDA Determined
Cause 2		Other
Quantity in Commerce1631 kits
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.
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