Recall Z-0558-06 ยท CDP Radioimmunoassay, Total Triiodothyronine
Tosoh Bioscience Inc
TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement of Total Triiodothyronine Human Serum. Each box of product contains 5 trays of 20 test cups per tray. Each tray is packaged in a foil pack. Both the box and foil packs have product labels.
| Date | Feb 23, 2006 (initiated Jan 26, 2006) |
| Status | Terminated |
| Reason | The inner foil packs of AIA-PACK ST TT3, Lot FX17440 contain an incorrect expiration date of 10/2005. The outer box is labeled with the correct expiration date of 10/2006. |
| Root cause | Other |
| Action | The recalling firm sent a letter, dated 1/26/06, to all consignees. |
| Quantity | 9 boxes |
| Distribution | KS, GA, TX, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936229 | AIA-PACK TT3 ASSAY Tosoh Medics, Inc., Jul 14, 1994 |