FDAClass IIIAugust 22, 2018

Tosoh Bioscience AIA Analyte Application Manual recall: Labeling Error

Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for…

Why was Tosoh Bioscience AIA Analyte Application Manual recalled?

Distribution of unapproved product labeling

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?

rev: 6.0-040418

Product
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for…
Recalling firm
Tosoh Bioscience Inc
Quantity
9 CDS
Distribution
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Recall date
August 22, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls