Agency classClass IIOur severity:High FDA (Devices)·Z-1577-2023·Announced 2023-05-17

STA Compact Max analyzer firmware bug causes inaccurate test results

A firmware bug in Diagnostica Stago's STA Compact Max analyzer causes intermittent shortened coagulation times and frequent technical errors that produce inaccurate lab test results. Five units were distributed to clinical laboratories nationwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The FDA classified this recall as Class II. The firmware defect directly affects clinical test result accuracy without any reported illnesses or injuries to date. Inaccurate coagulation times represent a risk-of-harm to patients if undetected.

Plain-English summary

The FDA is recalling the STA Compact Max fully automatic clinical analyzer (Reference Numbers 58602 and 58612) manufactured by Diagnostica Stago, Inc. This medical device is used in clinical laboratories for automated blood coagulation testing.

A firmware bug in affected units causes intermittent shortened coagulation times and an increased frequency of technical error messages (error 13). These malfunctions result in inaccurate test results.

Five analyzers with this defect were distributed nationwide in Illinois, Massachusetts, Minnesota, Nebraska, Texas, and Wisconsin. The device serial numbers affected are: 5061471, 5061474, 0000007405, CF70015885, and CF70015886.

The recalled product

Product: STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
Manufacturer: Diagnostica Stago, Inc.
Category: Medical Device — Clinical Laboratory Analyzer
Hazard: firmware-bug
inaccurate-results
device-malfunction
Affected units: 5

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: 036074505898
Serial Numbers: 5061471 5061474 0000007405 CF70015885 CF70015886

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 →

Same manufacturer · Diagnostica Stago, Inc.

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Same hazard · firmware bug