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Terminated

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.

FDA Recall Z-2773-2011 · Posted 2011-07-11

Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product Codendr
Date Initiated2011-03-31
Date Terminated2012-07-11
Product Quantity5521 units total for all products

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

Firm 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.

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002128ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100Diagnostic Systems Laboratories, Inc. · 2000-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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