510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0558-06

TOSOH ST AIA- PACK TT3, Lot FX17440, catalog #025282. This reagent is used for the quantitative measurement...

Tosoh Bioscience Inc / initiated 2006-01-26 / Terminated / root cause: labeling and UDI
FDA source (opens on fda.gov)

Tosoh Bioscience Inc began a recall of 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... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0558-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Tosoh Bioscience Inc
Product
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.
Product code
CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall
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 tag
labeling and UDI
FDA root cause
Other
Action
The recalling firm sent a letter, dated 1/26/06, to all consignees.
Quantity in commerce
9 boxes
Distribution
KS, GA, TX, WI
Product codes and lots
Lot #FX17440. The inner foil packs contain an ''incorrect'' expiration date of 10/2005. The outer box is labeled with the ''correct'' expiration date of 10/2006.