Recall Z-3128-2011 ยท NDR Enzyme Immunoassay, Inhibin-A
Beckman Coulter Inc.
Inhibin A ELISA, Part Number: DSL-10-28100-4 Product Usage: The Inhibin A ELISA kit is intended for the quantitative measurement of dimeric Inhibin A in human serum or plasma. It is intended strictly for in vitro use as an aid in the diagnosis and monitoring of various hormonal reproductive disorders.
| Date | Sep 2, 2011 (initiated Nov 10, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number DSL-10-28100-4), kit lot number 110761. |
| Root cause | Other |
| Action | Beckman Coulter initiated an "URGENT PRODUCT CORRECTION" on June 15, 2011, via a telephone script to the only one customer impacted by the recalled product. The telephone script provided an explanation of the problem identified and the actions to be taken. Beckman Coulter recommended that the customer discontinue use of the recalled product as a preventative measure. Beckman will send a representative to the customer's facility to replace the recalled product in all remaining kits of the affected lot. The customer was instructed to share this information with laboratory staff. For any que |
| Quantity | 342 units |
| Distribution | (USA) Nationwide Distribution in the state of CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.