Diagnostica Stago recalls STA Compact Automated Multi-Parametric Analyzer with firmware bug causing inconsistent coagulation test results. Affected units have reference numbers 58602 or 58612.
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).
Diagnostica Stago is recalling its STA Compact Automated Multi-Parametric Analyzer with reference numbers 58602 and 58612 due to a firmware bug that causes inconsistent coagulation test results. This could lead to inaccurate blood test results if the device is used without the fix.
The firmware bug causes the device to report shortened coagulation times and technical errors (error 13) more frequently. This could lead to inaccurate blood test results if the device is used without the fix.
Lab technicians and medical professionals who use the STA Compact Analyzer for blood tests may be affected. Those using the device for coagulation testing are most at risk of inaccurate results.
Check for reference numbers 58602 or 58612 on the device. The device has a unique identifier (UDI-DI: 036074505860) and serial numbers 7096527 or 7116678.
Verify if your device shows error 13 or inconsistent coagulation results.
Reach out to Diagnostica Stago for firmware updates or replacement options.
The recall is for a firmware bug that causes inconsistent test results, not a safety hazard. The risk is low and does not involve physical injury.
Check for reference numbers 58602 or 58612 on the device. The unique identifier (UDI-DI: 036074505860) and serial numbers 7096527 or 7116678 are also indicators.
Contact Diagnostica Stago for firmware updates or replacement options. The device may need to be checked for error 13 or inconsistent results.
We’ve drafted a message you can send Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1576-2023 — Stago Stago Hello, I own a Stago that is covered by recall Z-1576-2023 from Stago. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
