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Open, Classified

STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026

FDA Recall Z-1575-2023 · Posted 2023-05-10

Recalling FirmDiagnostica Stago, Inc.
Recall StatusOpen, Classified
Product CodeJPA
Date Initiated2023-03-22
Product Quantity6 analyzers

Reason for 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).

Firm Action

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.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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