CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product recalled
Tosoh Bioscience is recalling Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product, distributed nationwide in the US. The recall was initiated on 11 Jun 2017 and the FDA has classified it as Class II.
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-0491-2018
- FDA event ID
- 78776
- Recalling firm
- Tosoh Bioscience, Grove City, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jun 2017
- FDA classified
- 30 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 11 Jun 2017 | Recall initiated by company | |
| 30 Jan 2018 | Classified by FDA | +233 days |
| 7 Feb 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
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¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
Where it was distributed
Worldwide Distribution - U.S. Nationwide - Latin America
Questions about this recall
Is Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product recalled?
Yes. Tosoh Bioscience recalled Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product on 11 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0491-2018.
Why was it recalled?
This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current.
Which lots are affected?
All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003.
Where was it sold?
Worldwide Distribution - U.S. Nationwide - Latin America
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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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