Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative mea

FDA device recall Z-3128-2011 · posted 2011-09-02 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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

Status

Terminated

Product code

NDR

Quantity affected

342 units

Distribution

(USA) Nationwide Distribution in the state of CA

Date initiated

2010-11-10

Date posted

2011-09-02

Date terminated

2012-07-11

Location

Brea, CA