CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report
Beckman Coulter DxA Automation System, DxA recalled
Beckman Coulter Biomedical is recalling Beckman Coulter DxA Automation System, DxA 5000, distributed in 17 states. The recall was initiated on 2 Jun 2023 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-2144-2023
- FDA event ID
- 92484
- Recalling firm
- Beckman Coulter Biomedical, Munchen, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jun 2023
- FDA classified
- 14 Jul 2023
- Reported
- 26 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 2 Jun 2023 | Recall initiated by company | |
| 14 Jul 2023 | Classified by FDA | +42 days |
| 26 Jul 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
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
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Where it was distributed
US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,
AlabamaCaliforniaFloridaIllinoisKentuckyMichiganMinnesotaMissouriNebraskaNew JerseyNevadaNew YorkPennsylvaniaSouth CarolinaTexasWisconsinWest Virginia
Questions about this recall
Why was it recalled?
A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
Which lots are affected?
UDI-DI: (01)15099590707118, All DxA serial numbers
Where was it sold?
US: AL CA FL IL IN KY MI MN MO NE NJ NV NY OH PA SC TX WI WV OUS: Australia, Belgium, Canada, China, Croatia, Czechia, Egypt, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Malaysia, Netherlands, New Zealand, Poland, Saudi Arabia, Spain, Switzerland, United Kingdom,
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 92484This product is part of a recall event; the main page for the event is Beckman Coulter DxA Automation System, DxA 5000 Fit recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Beckman Coulter DxA Automation System, DxA 5000 Fit recalled | Beckman Coulter Biomedical | Device Malfunction | 17 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Remisol Advance recalled by Beckman Coulter Biomedical | Beckman Coulter Biomedical | Potency & Assay | 5 states |
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| Device | CLASS II | PE Centrifuge Temperature Controlled recalled | Beckman Coulter Biomedical | Foreign Material | Nationwide |
| Device | CLASS II | Beckman Coulter DxA Automation System, DxA 5000 Fit recalled | Beckman Coulter Biomedical | Device Malfunction | 17 states |
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