Recall Z-2772-2011 ยท NDR Enzyme Immunoassay, Inhibin-A
Beckman Coulter Inc.
Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 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.
| Date | Jul 11, 2011 (initiated Mar 31, 2011) |
| Status | Terminated |
| 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, Pe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002128 | ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 Diagnostic Systems Laboratories, Inc., Dec 5, 2000 |