The Recall Desk
HighFDA (Devices)·Z-0272-2022·Announced 2021-12-01

Clinical Chemistry Analyzer Software Defects May Produce Inaccurate Results

Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.

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 clinical chemistry systems. The software defects may produce inaccurate test results in critical diagnostic assays including cardiac, metabolic, infectious disease, and oncology testing. Although no illnesses or injuries have been reported, clinical chemistry analyzers are inherently risk-of-harm products. The recall meets High (3) criteria as a risk-of-harm medical device with theoretical but unconfirmed clinical impact.

Plain-English summary

Abbott Laboratories has recalled ARCHITECT clinical chemistry analyzer systems (models c4000, c8000, and c16000) running software version 9.41 and earlier. These systems are used in laboratory settings to measure various diagnostic assays.

The affected systems contain 12 software-related defects that may compromise measurement accuracy and result integrity. The defects include bypassing error codes, incorrect calibration, communication failures, missing quality control indicators, signal spikes, abnormal optical readings, and incorrect sample aspiration. These issues may result in inaccurate test results with unknown direction or magnitude of error.

7,535 systems are affected and have been distributed in the United States and internationally. Healthcare facilities using these systems should verify whether they are operating affected software versions.

The recalled product

Product
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
Manufacturer
Abbott Laboratories
Category
Medical Device — Clinical Chemistry Analyzer
Hazard
Affected units
7,535

Distribution

Distributed in 50 states:

Part of a larger recall action

This product is one of 2 recalled by Abbott Laboratories 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 2 products in this recall →

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