—#97616

Product

Inhibin A ELISA kit, Part Number: DSL-10-28100-4 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 #: 090779 (EXP: 02/04/2011), 091046 (EXP: 02/16/2011), 091053(EXP: 11/09/2011)

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-12-21
Posted by FDA: 2011-04-08
Terminated: 2012-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97616. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.