Food, drugs, devices › Beckman Coulter Biomedical GmbH
Device recall: DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sa
FDA enforcement event 85874 is a device recall by Beckman Coulter Biomedical GmbH of Munich, N/A, initiated 17 Jun 2020 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 916 device enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 24 Aug 2022. Initiation: voluntary: firm initiated. Beckman Coulter Biomedical GmbH has 4 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beckman Coulter Biomedical GmbH, Munich, N/A, Germany.
Reason for recall
"The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system ."
Distribution
"Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2983-2020 | DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a high-speed, modular, automated sample handling system that performs pre-analytical and post-analytical sample processing and storage. The automation system also sorts, routes, and presents sample tubes to analyzers for analysis.… | 32 units | Class II | Terminated | 30 Sep 2020 |
Context
Other enforcement events for Beckman Coulter Biomedical GmbH
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 29 Apr 2026 | REMISOL Advance with Software Version 2.5 UDI-DI code: 15099590802073 The Normand Info REMISOL Advance Data Manager coll | Device | Class II | 1 |
| 17 Jul 2024 | Power Express, REF B90918 | Device | Class II | 3 |
| 2 Jun 2023 | Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly | Device | Class II | 2 |
All 4 events for Beckman Coulter Biomedical GmbH
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has received complaints where the re-use of sample barcodes were not being detected by the system ."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide distribution including in the states of Illinois, Ohio, Pennsylvania, and West Virginia. The countries of Australia, Canada, China, Czech Republic, France,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Aug 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.