Beckman Coulter recall: DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1)… and 1 more product
Beckman Coulter Inc. is recalling Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1)… and 1 more product. The U.S. Food and Drug Administration published the recall on August 26, 2026; it began on July 15, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1)… and 1 more product |
| Brand | Beckman Coulter |
| Company | Beckman Coulter Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 15, 2026 |
| Published by FDA | August 26, 2026 |
| Recall ID | 99436 |
Recalled products (2)
- Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
- FDA recall number
- Z-2973-2026
- Codes, lots and dates
- 1) Part Number C63522, UDI/DI 14987666545089; 2) Part Number C63521, UDI/DI 14987666545072; 3) Part Number C13252, UDI/DI 15099590742331.
- Classification
- Class II
- Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
- FDA recall number
- Z-2974-2026
- Codes, lots and dates
- 1) Part Number C63519, UDI/DI 14987666545058 2) Part Number C63520, UDI/DI 14987666545065
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99436
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Brea, CA, United States
Why it was recalled
The reason the FDA lists: “a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Worldwide distribution - US Nationwide.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99436, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
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About this recall
Is Beckman Coulter Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1)… recalled?
Yes. Beckman Coulter Inc. recalled it on July 15, 2026; FDA published it August 26, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.