FDA Device recall Z-0491-2018
Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930
- FDA Device
- Class II
- terminated
- Published 2018-02-07
On 2018-02-07 the FDA classified a Class II recall of Tosoh¿Automated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930 by Tosoh Bioscience, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0491-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-11 |
| Published | 2018-02-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
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
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.
Identifiers
| code_info | All Photo Interrupter sensors that are current in AIA-900 analyzers with serial number(S/N) 10000103 to S/N 11147003. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.