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Terminated

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.

FDA Recall Z-0558-06 · Posted 2006-02-23

Recalling FirmTosoh Bioscience Inc
Recall StatusTerminated
Product CodeCDP
Date Initiated2006-01-26
Date Terminated2008-10-24
Product Quantity9 boxes

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.

Firm Action

The recalling firm sent a letter, dated 1/26/06, to all consignees.

Root Cause

Other

Distribution Pattern

KS, GA, TX, WI

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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