Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Ca
FDA device recall Z-3027-2011 · posted 2011-08-16 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KLI
- Quantity affected
- 2495 units total (2492 in US)
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Canada.
- Date initiated
- 2010-08-26
- Date posted
- 2011-08-16
- Date terminated
- 2012-07-11
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS TOTAL T4 ASSAY (K023369) | Beckman Coulter, Inc. | 2002-12-09 |