Recall Z-0673-2019— Tosoh Bioscience Inc

Name: FDA recall Z-0673-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Class II · Terminated

Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2018-11-30, terminated 2021-01-14. It names 2 FDA 510(k) clearances: K991252, K963687. 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..

Recalling firm: Tosoh Bioscience Inc
Classification: Class II
Status: Terminated
Initiated: 2018-11-30
Terminated: 2021-01-14
Firm location: Grove City, OH, United States

510(k) clearances named in this recall

2 on FDA's record

K991252 — AIA-PACK FT3 ASSAYTosoh Medics, Inc.·cleared 1999-05-11
K963687 — AIA-PACK FT3 ASSAYTosoh Medics, Inc.·cleared 1996-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.