FDAClass IIJanuary 2, 2019

AIA-PACK Folate recall

AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System…

Why was it recalled?

The source record does not provide a concise hazard summary.

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 Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System…
Recalling firm
Tosoh Bioscience Inc
Quantity
19366 units
Distribution
US Nationwide
Recall date
January 2, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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