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

FDA device recall Z-0558-06 · posted 2006-02-23 · Terminated

Recall details

Recalling firm
Tosoh Bioscience Inc
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.
Action taken
The recalling firm sent a letter, dated 1/26/06, to all consignees.
Root cause
Other
Status
Terminated
Product code
CDP
Quantity affected
9 boxes
Distribution
KS, GA, TX, WI
Date initiated
2006-01-26
Date posted
2006-02-23
Date terminated
2008-10-24
Location
Grove City, OH

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Related 510(k) clearances

RecordFirmDate
AIA-PACK TT3 ASSAY (K936229)Tosoh Medics, Inc.1994-07-14