Tosoh Bioscience recalls AIA Analyte Application Manual CD (part 997027) due to unapproved labeling. This CD contains manuals for 47 analyte reagent packs used with their AIA analyzers. Consumers should check if they own this CD and contact Tosoh for details.
Distribution of unapproved product labeling
Tosoh Bioscience is recalling a CD that contains analyte application manuals for their AIA analyzers. The recall is due to unapproved labeling on the CD, which could lead to incorrect use of the reagent packs.
The CD contains unapproved labeling for 47 analyte reagent packs. This could lead to incorrect use of the reagents if the labeling is not approved by regulatory authorities.
Users of Tosoh AIA analyzers who have the CD with part number 997027 are affected. Those who use the CD for reagent application are most at risk.
Check for the CD labeled 'Tosoh Bioscience AIA Analyte Application Manual (AAM)' with part number 997027. The CD contains manuals for 47 analyte reagent packs used with Tosoh AIA analyzers.
Look for the CD labeled 'Tosoh Bioscience AIA Analyte Application Manual (AAM)' with part number 997027.
The CD contains unapproved labeling for 47 analyte reagent packs used with Tosoh AIA analyzers.
Check if you have the CD with part number 997027 and contact Tosoh Bioscience for further instructions.
The recall is for unapproved labeling, which does not pose a direct injury risk but could lead to incorrect reagent use.
We’ve drafted a message you can send Tosoh Biosc: AIA Analyte Application Manual to request your refund or repair — edit it as you like.
Subject: Recall Z-2827-2018 — Tosoh Biosc: AIA Analyte Application Manual Tosoh Biosc: AIA Analyte Application Manual Hello, I own a Tosoh Biosc: AIA Analyte Application Manual that is covered by recall Z-2827-2018 from Tosoh Biosc: AIA Analyte Application Manual. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
