FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Inhibin A ELISA kit, Part Number: DSL-10-28100T-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.
- Recall number
- Z-1926-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- Inhibin A ELISA kit, Part Number: DSL-10-28100T-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.
- Status
- Terminated
- Initiated
- 2010-12-21
- Posted
- 2011-04-08
- Terminated
- 2012-08-31
- Reason
- 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
- Pending
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Lot #: 090498 (EXP: 02/04/2011), 090798 (EXP: 09/22/2011)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NDR
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28