Beckman Coulter - Manual Inhibin A ELISA Reagent Kit; Part Number DSL-10-28100-1 The Inhibin A enzyme-linked immunosorbe
FDA device recall Z-2772-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- ndr
- Quantity affected
- 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,
- Date initiated
- 2011-03-31
- Date posted
- 2011-07-11
- Date terminated
- 2012-07-11
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100 (K002128) | Diagnostic Systems Laboratories, Inc. | 2000-12-05 |