Recall Z-3027-2011 ยท KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems.
| Date | Aug 16, 2011 (initiated Aug 26, 2010) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534. |
| Root cause | Nonconforming Material/Component |
| Action | Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical S |
| Quantity | 2495 units total (2492 in US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023369 | ACCESS TOTAL T4 ASSAY Beckman Coulter, Inc., Dec 9, 2002 |