Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STA R Max fully automatic clinical instrument designed to perform Recalled by Diagnostica Stago, Inc. Due to An internal investigation identified a bug in this...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Diagnostica Stago, Inc. directly.
Affected Products
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Quantity: 6 analyzers
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Diagnostica Stago, Inc.
Diagnostica Stago, Inc. has 25 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report