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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94820

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 05, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beckman Coulter Mishima K.K.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2455-2024
Recall number
Z-2455-2024
Initiated
June 05, 2024
Classification
Class II
Status
Ongoing
Quantity
24 analyzers

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software bug issues with the analyzer. Issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Catalog Number: C63520 UDI-DI code: 14987666545065 Serial Numbers: 2023070010 2023060005 2023090015 2023070009 2023080011 2023080012 2023100019 2023100018 2023100020 2024010037 2024010036 2023110022 2024010038 2023090016 2024020040 2024020041 2024020039 2024020043 2024020042 2023110023 2024020045 2024020046 2024010024 2024010025

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.