—#103283

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.

FDA product code: NDR — Enzyme Immunoassay, Inhibin-A
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Lot # 110761

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: (USA) Nationwide Distribution in the state of CA

Timeline

Recall initiated: 2010-11-10
Posted by FDA: 2011-09-02
Terminated: 2012-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103283. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.