Recall Z-0671-2019— Tosoh Bioscience Inc

Name: FDA recall Z-0671-2019
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: K964348. Product: AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.. Reason: Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays.

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

K964348 — AIA-PACK B12 ASSAYTosoh Medics, Inc.·cleared 1997-01-13

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

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers.

Reason for recall

Potential for fluorescein interference to cause inaccurately elevated results for certain Tosoh AIA assays

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