Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Reported: July 26, 2023 Initiated: June 2, 2023 #Z-2145-2023
Product Description
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
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
Details
- Recalling Firm
- Beckman Coulter Biomedical GmbH
- Units Affected
- 15
- Distribution
- 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,
- Location
- Munchen, N/A
Frequently Asked Questions
What product was recalled? ▼
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly. Recalled by Beckman Coulter Biomedical GmbH. Units affected: 15.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on July 26, 2023. Severity: Moderate. Recall number: Z-2145-2023.
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