Recall Z-2178-2011 ยท JIT Calibrator, Secondary
Beckman Coulter Inc.
Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
| Date | May 10, 2011 (initiated Dec 17, 2009) |
| Status | Terminated |
| Reason | Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System do |
| Quantity | 2,320 kits |
| Distribution | Distribution Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042651 | FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS Beckman Coulter, Inc., Oct 5, 2004 |