DxI 9000 Access Immunoassay Analyzer — Class II medical device recall Z-0107-2024
Ongoing recall by Beckman Coulter, Inc., reported 2023-10-18, distributed nationwide. The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS,
| Recall number | Z-0107-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-09-12 |
| Classified | 2023-10-12 |
| Reported by FDA | 2023-10-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, CZ, DE, ES, FR, GB, HR, IE, IT, NL, NZ, ZA |
| Quantity | 36 units |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Model numbers | C11137 |
Product
DxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below; invitro diagnostic
Reason for recall
The firm has investigated and confirmed that when DxI 9000 is connected to Laboratory Information System (LIS, host), the sample barcode presented may be ignored and replaced with a sample ID that was previously in the same rack and position. This will cause a delay of result to the sample currently presented to the system (Sample B) and may result in an erroneous test result for the prior sample (Sample A), which gets associated with the results of sample B.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0107-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.