FDA Device recall Z-1575-2023
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
- FDA Device
- Class II
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 by Diagnostica Stago, citing an internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1575-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-22 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Diagnostica Stago |
| Distribution | US |
Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Reason
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).
Identifiers
| code_info | UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1575-2023%22
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