Lower riskMedical device recall · FDA · Published June 5, 2018
Tosoh AIA Analyte Manual CD Recall: Unapproved Labeling Hazard
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.
“Tosoh AIA Analyte Manual CD Recall: Unapproved Labeling Hazard.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70900-tosoh-aia-analyte-manual-cd-recall-unapproved-labeling-hazard. Based on FDA recall #Z-2827-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2827-2018%22&limit=1).
The FDA announced on June 5, 2018, that Tosoh Bioscience Inc voluntarily recalled the AIA Analyte Application Manual (AAM) CD due to distribution of unapproved product labeling. The recall affects 9 CDs distributed in Florida, Massachusetts, Montana, Oklahoma, Oregon, and Wisconsin.
The CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA family of analyzers. The hazard is the distribution of unapproved product labeling.
Context
GovInfoNow's records show Tosoh Bioscience Inc has 19 other recalls on record since June 11, 2017. Other recent recalls include the Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), the Tosoh AIA-Pack BHCG Calibrator Recall (August 7, 2020), and the Tosoh AIA-900 Analyzer Recall (May 22, 2020). Other recent recalls of similar products include the Leaky Gut Test Product Recall (November 3, 2025), the Siemens Atellica CH Urine Albumin Recall (July 6, 2026), and the Siemens SOMATOM X.ceed Software Applications Recall (December 19, 2025).
How to tell if you have this one
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.
Brand
Tosoh Biosc: AIA Analyte Application Manual
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check CD Details
Look for the CD labeled 'Tosoh Bioscience AIA Analyte Application Manual (AAM)' with part number 997027.
Where it went and when
Where it was distributed
Distributed in 6 states.
Listed by the agency
Not listed
FDA distribution: “US Distribution to states of: FL, MA, MT, OK, OR and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
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.
Official source: FDA Recall #Z-2827-2018 (June 5, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2827-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.