Tosoh Bioscience Recalls AIA Analyte Application Manual CDs
Tosoh Bioscience is recalling 9 AIA Analyte Application Manual CDs due to unapproved product labeling. The CDs were distributed to six US states.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences. The hazard is limited to documentation and labeling issues.
Plain-English summary
Tosoh Bioscience Inc is recalling 9 units of the AIA Analyte Application Manual (AAM) CD, Part Number 997027. The recall is due to the distribution of unapproved product labeling. The CD contains analyte application manuals for 47 analyte reagent packs used with the Tosoh AIA (Automated Immuno-Assay) family of analyzers.
The affected products were distributed in the United States to the states of Florida, Massachusetts, Montana, Oklahoma, Oregon, and Wisconsin. The specific revision code for the recalled items is 6.0-040418.
Consumers and healthcare facilities should stop using the affected CDs and contact Tosoh Bioscience Inc for further instructions or a replacement.
The recalled product
- Product
- Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference…
- Manufacturer
- Tosoh Bioscience Inc
- Hazard
- Affected units
- 9
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- rev: 6.0-040418
Distribution
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