Recall record at a glance
| Official record | Z-2145-2023 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Report date | Jul 26, 2023 |
| Recall initiation date | Jun 2, 2023 |
| Quantity | 15 |
| Location | Munchen, N/A, Germany |
Official product description
Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Why the product was 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
Distribution information
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,
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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