31

Jul

2024

FDA Recall: Calibration Errors May Lead to Erroneous Patient Results

0

Company: Beckman Coulter Mishima K.K.
Date of Enforcement Report: 7/31/2024
Class II

PRODUCT

DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

Recall Number:

Z-2455-2024

REASON:

There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.

RECALLING FIRM/MANUFACTURER:

Beckman Coulter Mishima K.K.

VOLUME OF PRODUCT IN COMMERCE:

24 analyzers

DISTRIBUTION:

Worldwide – U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL, MI, MN, MS, NE, NY, OR, PA and SC. The countries of Lebanon, and South Africa.

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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