FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
- Recall number
- Z-2773-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides materials for the quantitative measurement of dimeric inhibin A in human serum and plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
- Status
- Terminated
- Initiated
- 2011-03-31
- Posted
- 2011-07-11
- Terminated
- 2012-07-11
- Reason
- The recall was initiated because patient results are falsely elevated by approximately 30% because the reference standard of the Manual Inhibin A ELISA assay has shifted from the assays original calibration. Erroneously elevated results may lead to unnecessary ultrasound testing to confirm gestational age, patient psychological stress until diagnostic testing is completed, and/or medical decis
- Root cause
- Process design
- Action
- Beckman Coulter sent an "Urgent Product Correction" letter dated March 31, 2011 to all affected customers. The letter included an explanation of the problem and recommendations including; discontinue use of the kit and a Response Form to fill out and return. For additional information contact the Beckman Coulter Customer Support Center at 1-800-854-3633 or your local Beckman Coulter representative.
- Quantity
- 5521 units total for all products
- Distribution
- Worldwide distribution: (USA) Nationwide and the countries of Armenia, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Jordan, Republic of Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Peru, Portugal, Romania, Russian Federation, Serbia, Slovenia, Spain, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
- Lot, serial or model codes
- Lot Number: 992221, 992364, 992707, 090096, 090497, 090799
- 510(k) numbers
- ["K002128"]
- 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