Recall Z-1925-2011 ยท NDR Enzyme Immunoassay, Inhibin-A
Beckman Coulter Inc.
Inhibin A ELISA kit, Part Number: DSL-10-28100-4 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 | Apr 8, 2011 (initiated Dec 21, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit. |
| Root cause | Pending |
| Action | Beckman Coulter sent an Urgent Product Corrective Action letter dated December 21, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product and discard all remaining inventory. In addition customers were requested to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form within 10 days so Beckman |
| Quantity | 740 total units for both products |
| Distribution | Worldwide Distribution - USA including NY, IN, PA, NM, OH, TX, AZ, NC, TN, MI and CT and the countries Denmark, Germany, Spain, Turkey, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.