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Recall Observatory FDA recall evidence

Device product

ST AIA-PACK FT3 (FT3: Free Triiodothyronine) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine (FT3) in human serum or heparinized plasma on specific Tosoh AIA System analyzers.

Z-0673-2019

November 30, 2018

Class II

Product summary

Firm
Tosoh Bioscience Inc
Event
Event 81597
Status
Terminated
Classification
Class II
Quantity
24083 units
Official record key
device-enforcement:Z-0673-2019

Official wording

Reason: Unavailable

Code information: all lots

Distribution pattern: US Nationwide