FDAClass IIJanuary 2, 2019

Aia-pack B12 recall

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…

Why was Aia-pack B12 recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

all lots

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…
Recalling firm
Tosoh Bioscience Inc
Quantity
29645 units
Distribution
US Nationwide
Recall date
January 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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