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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 06, 2002
Date Posted January 30, 2003
Recall Status1 Terminated 3 on July 26, 2003
Recall Number Z-0494-03
Recall Event ID 25392
510(K)Number K955769  
Product Classification Radioimmunoassay, Progesterone - Product Code JLS
Product Access Progesterone Assay, Part number 33550.
Code Information All Lots.
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynne McBride
Manufacturer Reason
for Recall
Primary tube sampling issue may cause false low results.
FDA Determined
Cause 2
Action Recall letters were sent to customers on 12/6/2002 informing them to not process the sample directly from the primary collection tubes but to pour off a bit into a separate tube. Labs are to incorporate this into their Standard Operating Procedures until the firm can identify another resolution to the problem.
Quantity in Commerce 6,655
Distribution USA and Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JLS and Original Applicant = BIO-RAD LABORATORIES, INC.