Stago STA Compact Analyzer Recall: Firmware Bug Causes Inconsistent Test Results
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.
Lower-risk 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).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/58679-stago-sta-compact-analyzer-recall-firmware-bug-causes-inconsistent-test.
Source Summary by GovInfoNow · govinfonow.com/recall/58679-stago-sta-compact-analyzer-recall-firmware-bug-causes-inconsistent-test · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1576-2023
Cite this page
“Stago STA Compact Analyzer Recall: Firmware Bug Causes Inconsistent Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58679-stago-sta-compact-analyzer-recall-firmware-bug-causes-inconsistent-test. Based on FDA recall #Z-1576-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1576-2023%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Stago- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1575-2023 | STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026; UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744 | 6 analyzers |
| Z-1576-2023 | STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612; UDI-DI: 036074505860; Serial Numbers: 7096527 7116678 | 2 analyers |
| Z-1577-2023 | STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612; UDI-DI: 036074505898; Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886 | 5 analyzers |
What to do — step by step
Check Device Status
Verify if your device shows error 13 or inconsistent coagulation results.
Contact Manufacturer
Reach out to Diagnostica Stago for firmware updates or replacement options.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Massachusetts, Minnesota, Nebraska, Texas, Wisconsin.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this recall dangerous?
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.
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Where this comes from
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.
- Official source: FDA Recall #Z-1576-2023 (March 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1576-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.