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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 FirmDecember 22, 2003
Date PostedJanuary 29, 2004
Recall Status1 Terminated 3 on May 24, 2004
Recall NumberZ-0374-04
Recall Event ID 28017
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
ProductICON 25 hCG test kit.
Code Information Lot HCG030732
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Test can exhibit false negative results.
FDA Determined
Cause 2		Other
ActionCustomer letter was sent 12/22/03 via US Mail. It instructs users to discontinue use of product for replacement.
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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