CLASS III Device recall · Reported 22 Aug 2018 · FDA Enforcement Report
AIA Analyte Application Manual (AAM) CD recalled by Tosoh Bioscience
Tosoh Bioscience is recalling Tosoh Bioscience AIA Analyte Application Manual (AAM) CD, distributed in Florida, Massachusetts, Montana, Oklahoma, Oregon, Wisconsin. The recall was initiated on 5 Jun 2018 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2827-2018
- FDA event ID
- 80482
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2018
- FDA classified
- 15 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jun 2018 | Recall initiated by company | |
| 15 Aug 2018 | Classified by FDA | +71 days |
| 22 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distribution of unapproved product labeling
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 controls in the analyte application manual.
Where it was distributed
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Questions about this recall
Is AIA Analyte Application Manual (AAM) CD recalled?
Yes. Tosoh Bioscience recalled AIA Analyte Application Manual (AAM) CD on 5 Jun 2018. The recall is Class III and its status is Terminated. Recall number Z-2827-2018.
Why was it recalled?
Distribution of unapproved product labeling
Which lots are affected?
rev: 6.0-040418
Where was it sold?
US Distribution to states of: FL, MA, MT, OK, OR and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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