STA R Max fully automatic clinical instrument designed to… recallZ-1575-2023 · Diagnostica Stago, Inc. · initiated Mar 22, 2023
Class II Open, Classified All recalls posted in May 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostica Stago, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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).
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1575-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Mar 22, 2023
- Posted by the FDA
- May 10, 2023
- Recalling firm
- Diagnostica Stago, Inc.
- Quantity
- 6 analyzers
- Product code
- JPA
- FDA submissions
- K151867
- Distribution
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
Product description
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Code information (models, lots, serial numbers)
UDI-DI: 036074505901; Serial Numbers: CP86010393 DB68093186 CP87010814 CP86070669 CP86090743 CP86090744
Other devices under the same FDA submission
2 devices cleared under K151867 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STA R Max® (with cap piercing option) 59010Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES2 reports
- STA R Max® (with cap piercing option) 59027Diagnostica Stago · SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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