Diagnostica Stago, Inc. STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Brand
Diagnostica Stago, Inc.
Lot Codes / Batch Numbers
UDI-DI: 036074505901, Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
Products Sold
UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
Diagnostica Stago, Inc. is recalling STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference due to An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Customers were contacted via telephone and an URGENT: MEDICAL DEVICE CORRECTION notification letter beginning 3/22/23. Actions: Stago downgraded your firmware to the previous firmware version as a precaution. Your downgrade has already occurred. Consequently, the risk of this bug only existed during the time period shown above (i.e. from new firmware installation date to the downgrade date). As patient results are interpreted in association with other biological tests, we leave the decision to review previous patient results based on the complete clinical context to your discretion. Our Customer Service team is available to help you carry out your impact analysis. For additional information, please contact your Stago Hotline at 1-800-725-0607.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026