Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in sampl

Recalled August 7, 2024 · FDA recall Z-2455-2024 · Beckman Coulter Mishima K.K

Hazard

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. · FDA Class II

Units

24 analyzers

Sold at

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.

Description

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.

Manufacturer(s)

Beckman Coulter Mishima K.K.

Made in

Japan

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →