Beckman Coulter Mishima K.K.: Device Recall

Recall Details

Recall Number

Z-2455-2024

Classification

Class II

Product Type

Device

Recalling Firm

Beckman Coulter Mishima K.K.

Status

Ongoing

Date Initiated

06/05/2024

Location

Sunto-Gun, N/A, Japan

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

24 analyzers

Reason for Recall

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.

Product Description

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.

Distribution Pattern

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.

Other Recalls by Beckman Coulter Mishima K.K.

• Class II: Risk 04/30/2025
  A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
• Class II: Risk 04/30/2025
  Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
• Class II: Risk 07/10/2024
  Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.

View all recalls by Beckman Coulter Mishima K.K. →