Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC Recalled by Tosoh Bioscience Inc Due to Potential for fluorescein interference to cause inaccurately elevated...

Date: November 30, 2018
Company: Tosoh Bioscience Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tosoh Bioscience Inc directly.

Affected Products

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.

Quantity: 29645 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Tosoh Bioscience Inc

Tosoh Bioscience Inc has 68 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report