Recall Z-0675-2019— Tosoh Bioscience Inc

Name: FDA recall Z-0675-2019
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 one FDA 510(k) clearance: K121533. Product: ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria..

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

1 on FDA's record

K121533 — ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SETTosoh Bioscience, Inc.·cleared 2012-06-15

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 Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.

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