The Recall Desk
HighFDA (Devices)·Z-1576-2023·Announced 2023-05-17

STA Compact Analyzer Firmware Bug Causes Inaccurate Test Results

Diagnostica Stago is recalling STA Compact Analyzers due to a firmware bug causing intermittent shortened coagulation times and increased technical errors. No illnesses or injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a firmware defect affecting test result accuracy. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' resulting in a High severity score.

Plain-English summary

Diagnostica Stago, Inc. is recalling the STA Compact Automated Multi-Parametric Analyzer (Reference Numbers 58602 and 58612) due to a firmware bug identified during an internal investigation. The analyzers were distributed nationwide, with confirmed distribution in Illinois, Massachusetts, Minnesota, Nebraska, Texas, and Wisconsin.

The firmware bug can cause intermittent shortened coagulation times in test results and an increased frequency of technical error messages (error 13). These malfunctions may result in inaccurate patient test results that could affect clinical decisions.

Facilities using these analyzers should contact Diagnostica Stago, Inc. for instructions on applying a firmware update or other remedial actions. No illnesses or injuries have been reported.

The recalled product

Product
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Laboratory Diagnostic Equipment
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • UDI-DI: 036074505860
  • Serial Numbers: 7096527 7116678

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Diagnostica Stago, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Diagnostica Stago, Inc.

See all →

Same hazard · firmware bug

See all →