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AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative meas...

FDA Recall #Z-0671-2019 — Class II — November 30, 2018

Recall #Z-0671-2019 Date: November 30, 2018 Classification: Class II Status: Terminated

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

Recalling Firm

Tosoh Bioscience Inc — Grove City, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

29645 units

Distribution

US Nationwide

Code Information

all lots

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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