Z-2773-2011

Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked...

Name: Z-2773-2011 Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked...
Creator: Beckman Coulter Inc.
Published: 2011-03-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-03-31 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100t-1 The Inhibin A enzyme-linked immunosorbent assay (ELISA) kit provides... on 2011-03-31. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2773-2011
Status: Terminated
Initiated: 2011-03-31
Posted: 2011-07-11
Terminated: 2012-07-11
Recalling firm: Siemens Healthcare Diagnostics 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.
Product code: ndr
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: Lot Number: 992221, 992364, 992707, 090096, 090497, 090799

Product code ndr

K002128Class IActive Inhibin-a Elisa, Model Dsl-10-28100Diagnostic Systems Laboratories, Inc. / cleared 2000-12-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)