Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2827-2018 — 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 section on assay control

U.S. FDA — Device Enforcement · United States · 2018-06-05 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2827-2018
Date of alert: 2018-06-05
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Tosoh Bioscience Inc
Product category: device
Product type: Devices

Reported risk: Distribution of unapproved product labeling

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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