ABX Micros IM2 — Class III medical device recall Z-1050-2013
Terminated recall by Horiba Instruments, Inc dba Horiba Medical, reported 2013-04-10, distributed nationwide. Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient tes
| Recall number | Z-1050-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical, Irvine, CA, United States |
| Recall initiated | 2013-02-15 |
| Classified | 2013-04-03 |
| Reported by FDA | 2013-04-10 |
| Terminated | 2014-08-11 |
| Distributed | Nationwide (US) |
| Quantity | 180 units |
| Model numbers | D00A00202, IM2, M60CSB110EN04 |
Product
ABX Micros IM2, Part# M60CSB110EN04 and D00A00202 The IM2 Data Management System consists of the IM2 Data Manager Software, Desktop Computer, keyboard, mouse, and a unidirectional serial cable. The IM2 software is used to store, retrieve, and process laboratory data received via a unidirectional serial connection from the ABX Micros 60.
Reason for recall
Horiba Medical is recalling ABX Micros IM2 Data Management System because it may display incorrect patient test results under unanticipated operating conditions.
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-1050-2013. 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.