Tosoh Bioscience Inc: Medical Device Recall in 2019 - (Recall #: Z-0671-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 30, 2018

Date Posted: January 2, 2019

Recall Number: Z-0671-2019

Event ID: 81597

Reason for Recall:

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

Status: Terminated

Product Quantity: 29645 units

Code Information:

all lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated