Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 30, 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. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
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 bein…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter Biomedical GmbH recalled DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a hi… - a moderate-severity action.
DxA 5000; Catalog Number:B50516; UDI:15099590707118 - Product Usage: The DxA 5000 is a hi… was recalled by Beckman Coulter Biomedical GmbH in September 30, 2020. Reason: The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has r…. Check the official notice for the remedy. Verify recall #Z-2983-2020 with the FDA Devices before acting.
The recall
Beckman Coulter Biomedical GmbH issued this moderate-severity FDA Devices recall-The DxA 5000 instructions for use may be confusing regarding the re-use of sample IDs. Beckman Coulter has r….
- Moderate
- severity level
- 32 units
- affected scope
- Class II
- classification
- September 30, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2983-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2983-2020) was formally reported on September 30, 2020, with the manufacturer initiating the action on June 17, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Beckman Coulter Biomedical GmbH is listed as the recalling firm, operating out of Munich, N/A. Federal records list the affected scope as 32 units.
The documented reason for this recall is: 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 data in the federal record shows the product reached: 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, Israel, Italy, Germany, …. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
32 units
Related Recalls
6
3 from same agency
Product description
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. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.
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 .
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2983-2020 |
| Date reported | September 30, 2020 |
| Date initiated | June 17, 2020 |
| Recalling firm | Beckman Coulter Biomedical GmbH |
| Firm location | Munich, N/A |
| Affected scope | 32 units |
| 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, Israel, Italy, Germany, Switzerland, Spain, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2983-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. The DxA 5000 also consolidates a variety of analytical instruments, such as an Immunoassay analyzer, into a unified workstation on a track system.. Recalled by Beckman Coulter Biomedical GmbH. Units affected: 32 units.
Why was this product recalled? ▼
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 .
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 30, 2020. Severity: Moderate. Recall number: Z-2983-2020.
Where was the recalled product distributed? ▼
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, Israel, Italy, Germany, Switzerland, Spain, Netherlands, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2983-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 30, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.