Recall Z-2658-2010 ยท CEC Radioimmunoassay, Free Thyroxine
Beckman Coulter Inc.
Access Immunoassay Systems Free T4, Part Number: 33880
| Date | Oct 1, 2010 (initiated Mar 24, 2010) |
| Status | Terminated |
| Reason | The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results. |
| Root cause | Other |
| Action | A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled as Vitamin B12 Lot 916277. The PCA requested customers: (1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (2) Inspect your Acce |
| Quantity | 10826 |
| Distribution | Nationwide In the US & Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982250 | ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER Beckman Instruments, Inc., Jul 14, 1998 |