STA R Max fully automatic clinical instrument designed to perform… — Class II medical device recall Z-1575-2023
Ongoing recall by Diagnostica Stago, Inc., reported 2023-05-17, distributed nationwide. An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent s
| Recall number | Z-1575-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diagnostica Stago, Inc., Parsippany, NJ, United States |
| Recall initiated | 2023-03-22 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 6 analyzers |
| Reason classes | software |
| Serial numbers | CP86010393, CP86070669, CP86090743, CP86090744, CP87010814, DB68093186 |
Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Reason for recall
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
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-1575-2023. 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.