Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 9, 2025
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are …
Beckman Coulter Inc. recalled DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 149876665450… - a moderate-severity action.
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 149876665450… was recalled by Beckman Coulter Inc. in April 9, 2025. Reason: Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defec…. Check the official notice for the remedy. Verify recall #Z-1517-2025 with the FDA Devices before acting.
The recall
Beckman Coulter Inc. issued this moderate-severity FDA Devices recall-Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defec….
- Moderate
- severity level
- Class II
- classification
- April 9, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1517-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1517-2025) was formally reported on April 9, 2025, with the manufacturer initiating the action on February 26, 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 Brea, CA. Federal records list the affected scope as 143 systems (U.S. 74 and O.U.S. 69).
The documented reason for this recall is: Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the op… Distribution data in the federal record shows the product reached: Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, B…. 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
143 systems (U.S. 74 and O.U.S. 69)
Related Recalls
6
3 from same agency
Product description
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason for recall
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1517-2025 |
| Date reported | April 9, 2025 |
| Date initiated | February 26, 2025 |
| Recalling firm | Beckman Coulter Inc. |
| Firm location | Brea, CA |
| Affected scope | 143 systems (U.S. 74 and O.U.S. 69) |
| Distribution | Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, C… |
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-1517-2025) 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? ▼
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.. Recalled by Beckman Coulter Inc.. Units affected: 143 systems (U.S. 74 and O.U.S. 69).
Why was this product recalled? ▼
Beckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent tests of a calculated result are rerun, either manually ordered by the operator at the analyzer or automatically triggered by predefined rules in System Configuration, the calculated result will not be recalculated using the constituent tests rerun results. The system will report only the calculated result using the initial constituent tests results to the operator and LIS/Remisol. The issue was identified by Beckman Coulter internal engineering testing. The defect may cause a delay in reporting patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 9, 2025. Severity: Moderate. Recall number: Z-1517-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: U.S. (nationwide) to states of: AL, CA, CO, GA, ID, IL, IN, LA, MA, AI, MN, MS, MT, NC, NM, NV, NY, OK, OR, PA, PR, SC, TN, TX, WA, and WI; O.U.S. (foreign) to countries of: Australia, Belgium, Bosnia/Herzegovina, Canada, Croatia, Egypt, Ethiopia, France, Germany, Ghana, India, Italy, Republic of Korea, Lebanon, Libya, Malaysia, Netherlands, North Macedonia, Oman, Paraguay, Philippines, Poland, Qatar, Saudi Arabia, Seychelles, Slovakia, South Africa, Spain and Switzerland.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1517-2025) 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 April 9, 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.