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Terminated

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.

FDA Recall Z-3128-2011 · Posted 2011-09-02

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeNDR
Date Initiated2010-11-10
Date Terminated2012-07-11
Product Quantity342 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

(USA) Nationwide Distribution in the state of CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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