Inhibin A ELISA kit, Part Number: DSL-10-28100-4 The Inhibin A ELISA kit is intended for the quantitative measurement of

FDA device recall Z-1925-2011 · posted 2011-04-08 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit.

Action taken

Beckman Coulter sent an Urgent Product Corrective Action letter dated December 21, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and discard all remaining inventory. In addition customers were requested to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form within 10 days so Beckman could be assured that customers received this important notification. For product replacement: 1. In the United States, please contact Customer Service at 1-800-526-3821, option 1. 2. In Canada, please contact Customer Service at 1-800-463-7828. 3. Outside of the United States and Canada, contact your local Beckman Coulter representative. Customers who needed assistance or had any questions regarding this notification, were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. For those customers outside the United States and Canada, instructions were given to contact their local Beckman Coulter representative.

Root cause

Pending

Status

Terminated

Product code

NDR

Quantity affected

740 total units for both products

Distribution

Worldwide Distribution - USA including NY, IN, PA, NM, OH, TX, AZ, NC, TN, MI and CT and the countries Denmark, Germany, Spain, Turkey, United Arab Emirates, United Kingdom.

Date initiated

2010-12-21

Date posted

2011-04-08

Date terminated

2012-08-31

Location

Brea, CA