Diagnostica Stago recalls STA R Max clinical instruments with firmware bug causing inaccurate coagulation test results. Affected units have specific reference numbers and serials. Contact for remedy.
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 St:ago recalls its STA R Max clinical instruments due to a firmware bug that causes inaccurate coagulation test results. This could lead to incorrect medical diagnoses if used without the fix.
The firmware bug causes intermittent shortened coagulation times and increased technical errors (error 13) in blood tests. This could lead to incorrect medical diagnoses if the device is used without the fix.
Healthcare professionals using the STA R Max clinical instruments for blood tests are most at risk. Patients receiving tests from these devices may be affected if the results are inaccurate.
Check for reference numbers 59013 or 59026 on the device. Serial numbers include CP86010393, DB68093186, CP87010814, CP86070669, CP86090743, or CP86090744.
Identify reference numbers 59013 or 59026 and serial numbers listed in the recall notice.
The recall is for a firmware bug that causes inaccurate test results, not immediate danger. The risk is low but requires correction.
Check the device for reference numbers 59013 or 59026 and serial numbers listed in the recall notice. Contact Diagnostica Stago for remedy.
The bug causes intermittent shortened coagulation times and increased technical errors (error 13), potentially leading to inaccurate blood test results.
We’ve drafted a message you can send Diagnostica Stago to request your refund or repair — edit it as you like.
Subject: Recall Z-1575-2023 — Diagnostica Stago Diagnostica Stago Hello, I own a Diagnostica Stago that is covered by recall Z-1575-2023 from Diagnostica 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.
