PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 2, 2019 Initiated: November 30, 2018 #Z-0673-2019

Product Description

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.

Details

Recalling Firm
Tosoh Bioscience Inc
Units Affected
24083 units
Distribution
US Nationwide
Location
Grove City, OH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Tosoh Bioscience Inc. Units affected: 24083 units.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 2, 2019. Severity: Moderate. Recall number: Z-0673-2019.