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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 FirmSeptember 04, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on January 04, 2005
Recall NumberZ-1026-04
Recall Event ID 28908
Product Classification Colorimetry, Acetaminophen - Product Code LDP
ProductSynchron Systems Acetaminophen Reagent, part No. 472169.
Code Information All lots
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		Firm shortened calibration frequency to 7 days from 14 days.
FDA Determined
Cause 2		Other
ActionFirm issued letters to customers indicating need to shorten the calibration period from 14 to 7 days.
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.
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