CLASS II ONGOING Device recall · Reported 7 Aug 2024 · FDA Enforcement Report
DxC 500 AU Clinical Chemistry Analyzer recalled
Beckman Coulter Mishima K.K is recalling DxC 500 AU Clinical Chemistry Analyzer, distributed nationwide in the US. The recall was initiated on 5 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2455-2024
- FDA event ID
- 94820
- Recalling firm
- Beckman Coulter Mishima K.K, Sunto-Gun, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Jun 2024
- FDA classified
- 31 Jul 2024
- Reported
- 7 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 5 Jun 2024 | Recall initiated by company | |
| 31 Jul 2024 | Classified by FDA | +56 days |
| 7 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaCaliforniaGeorgiaHawaiiIllinoisMichiganMinnesotaMississippiNebraskaNew YorkOregonPennsylvaniaSouth Carolina
Questions about this recall
Is DxC 500 AU Clinical Chemistry Analyzer recalled?
Yes. Beckman Coulter Mishima K.K recalled DxC 500 AU Clinical Chemistry Analyzer on 5 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2455-2024.
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beckman Coulter Mishima K.K
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DxC 700 AU recalled by Beckman Coulter Mishima K.K | Beckman Coulter Mishima K.K | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Chemistry Analyzer Au5800 recalled by Beckman Coulter Mishima K.K | Beckman Coulter Mishima K.K | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Sample probe sucks a sample dispensed into a tube or cup recalled | Beckman Coulter Mishima K.K | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Sample probe sucks a sample dispensed into a tube or cup recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Chemistry Analyzer recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |