Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported June 11, 2025
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may requir…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Beckman Coulter, Inc. recalled DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 - a moderate-severity action.
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20 was recalled by Beckman Coulter, Inc. in June 11, 2025. Reason: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being…. Check the official notice for the remedy. Verify recall #Z-1913-2025 with the FDA Devices before acting.
The recall
Beckman Coulter, Inc. issued this moderate-severity FDA Devices recall-A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being….
- Moderate
- severity level
- 231 units
- affected scope
- Class II
- classification
- June 11, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1913-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1913-2025) was formally reported on June 11, 2025, with the manufacturer initiating the action on April 23, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Beckman Coulter, Inc. is listed as the recalling firm, operating out of Chaska, MN. Federal records list the affected scope as 231 units.
The documented reason for this recall is: A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United King…. 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
231 units
Related Recalls
6
3 from same agency
Product description
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
Reason for recall
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1913-2025 |
| Date reported | June 11, 2025 |
| Date initiated | April 23, 2025 |
| Recalling firm | Beckman Coulter, Inc. |
| Firm location | Chaska, MN |
| Affected scope | 231 units |
| Distribution | Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain… |
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-1913-2025) 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? ▼
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20. Recalled by Beckman Coulter, Inc.. Units affected: 231 units.
Why was this product recalled? ▼
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2025. Severity: Moderate. Recall number: Z-1913-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Kazakhstan, Spain, Germany, Italy, Belgium, Croatia, Taiwan, Province of China, Poland, India, Singapore, Switzerland, France, Libya, United Kingdom of Great Britain and Northern Irland, Oman, Algeria, Czechia, Korea, Public of, Slovakia, Croatia, Cote d'lvoire, Australia, Ireland, Taiwan, Province of China, New Zealand, Austria, Hungary, Brazil, Israel, Portugal..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1913-2025) 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 June 11, 2025. 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.