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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 FirmJuly 30, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 30, 2004
Recall NumberZ-1101-04
Recall Event ID 28961
510(K)NumberK974452 
Product Classification Multi-Analyte Controls, All Kinds (Assayed) - Product Code JJY
ProductSynchron Systems Hemoglobin A1c (HbA1c) Reagent
Code Information Part 650252  Product Lot Numbers: M206003 M209057
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
Manufacturer Reason
for Recall		Results of tests are biased low due to a vendor change in formulation not brought to the attention of the recalling firm.
FDA Determined
Cause 2		Other
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 = JJY
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