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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 29, 2004
Date PostedAugust 17, 2004
Recall Status1 Terminated 3 on February 03, 2005
Recall NumberZ-1378-04
Recall Event ID 29690
510(K)NumberK984014 
Product Classification Calibrator, Multi-Analyte Mixture - Product Code JIX
ProductSYNCHRON Clinical Systems Enzyme Validator Kit
Code Information M310400
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		incorrect Calibration Acceptance Limits.
FDA Determined
Cause 2		Other
ActionRecall letter sent 07/29/2004, informing customers to discard all calibration diskettes and load a new calibration diskette.
Quantity in Commerce771
DistributionNationwide & 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 = JIX
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