Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900 — Class II medical device recall Z-0491-2018
Terminated recall by Tosoh Bioscience Inc, reported 2018-02-07, distributed nationwide. This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential mal
| Recall number | Z-0491-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Bioscience Inc, Grove City, OH, United States |
| Recall initiated | 2017-06-11 |
| Classified | 2018-01-30 |
| Reported by FDA | 2018-02-07 |
| Terminated | 2019-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 565 devices |
| Reason classes | device malfunction |
| Serial numbers | 10000103, 11147003 |
| Model numbers | 022930 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0491-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.