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.
Recall
- Recall Number
- Z-3027-2011
- Event Number
- 59239
- Firm
- Beckman Coulter Inc.
- FEI Number
- 2050012
- Product Code
- KLI
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 26, 2010
- Posted
- August 16, 2011
- Terminated
- July 11, 2012
- Address
- 250 S Kraemer Blvd, Brea, CA, 92821-6232
Description
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.
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.
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.
Worldwide Distribution-USA (nationwide) and the country of Canada.
2495 units total (2492 in US)