Recall Z-3027-2011
Beckman Coulter Inc. · initiated August 26, 2010
Product
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.
Codes / lots: Lot Number: 917074, 008534 Expiration Date: 917074 (12/31/10), 008534 (2/28/11)
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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 Support at (800) 854-3633 or contact their local Beckman Coulter representative.
Details
- Recall number
- Z-3027-2011
- Initiated
- August 26, 2010
- Posted by FDA
- August 16, 2011
- Terminated
- July 11, 2012
- Product code
- KLI – Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- Quantity
- 2495 units total (2492 in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Recalling firm
- Beckman Coulter Inc., Brea, CA