FDA Device recall Z-2423-2020
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
- FDA Device
- Class II
- terminated
- Published 2020-07-01
On 2020-07-01 the FDA classified a Class II recall of AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 by Tosoh Bioscience, citing the Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2423-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-22 |
| Published | 2020-07-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tosoh Bioscience |
| Distribution | US |
Product
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992
Reason
The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
Identifiers
| code_info | From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial num…From customer letter: Serial numbers 10030810; 10101008; 10142204; 10212411; 10253902; 10263902 and higher serial numbers Complete list: (Distributed in US) 10030810 10050912 10071402 10101008 10142204 10162305 10202911 10212411 10222312 10253902 10263902 10273002 10303104 10303904 10313105 10313605 10333005 10333906 10343006 10343307 10353507 10353607 10353707R 10353807 10353907 10363507 10363608 10373108 10373408 10373508 10393108 10393208 10393308 10393908 10413009 10413509 10423409 10423909 10433009 10443110 10443210 10443310 10443710 10453310 10453410 10453810 10453910 10463010 10463110 10473111 10473211 10473311 10473411 10483411 10483511 10493111 10493411 10493711 10493911 10503011 10503111 10503211 10503311 10503612 10503912 10513412 10523912 10533012 10533112 10533212 10533412 10533612 10543012 10543212 10543412 10543512 10574301 10574601 10584702 10594502 10594602 10594702 10604902R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2423-2020%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.