Date Initiated by Firm | November 10, 2010 |
Date Posted | September 02, 2011 |
Recall Status1 |
Terminated 3 on July 11, 2012 |
Recall Number | Z-3128-2011 |
Recall Event ID |
59685 |
Product Classification |
Enzyme immunoassay, inhibin-a - Product Code NDR
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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/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact | Clair K. O'Donovan, Ph.D. 714-961-4483 |
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 | Other |
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 |
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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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