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U.S. Department of Health and Human Services

Class 3 Device Recall Inhibin A ELISA

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 Class 3 Recall
Inhibin A ELISA
see related information
Date Posted September 02, 2011
Recall Status1 Terminated on July 11, 2012
Recall Number Z-3128-2011
Recall Event ID 59685
Product Classification Enzyme Immunoassay, Inhibin-A - Product Code NDR
Product Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
Code Information Lot # 110761
Recalling Firm/
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea, California 92821-6232
For Additional Information Contact Clair K. O'Donovan, Ph.D.
Manufacturer Reason
for Recall
The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761.
FDA Determined
Cause 2
Action Beckman Coulter initiated an "URGENT PRODUCT CORRECTION" on June 15, 2011, via a telephone script to the only one customer impacted by the recalled product. The telephone script provided an explanation of the problem identified and the actions to be taken. Beckman Coulter recommended that the customer discontinue use of the recalled product as a preventative measure. Beckman will send a representative to the customer's facility to replace the recalled product in all remaining kits of the affected lot. The customer was instructed to share this information with laboratory staff. For any questions concerning this information, contact Beckman Coulter at 952-368-7874.
Quantity in Commerce 342 units
Distribution (USA) Nationwide Distribution in the state of CA
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.