DxI 9000 Access Immunoassay Analyzer running software version 1 — Class II medical device recall Z-0982-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-02-14, distributed nationwide. There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access
| Recall number | Z-0982-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2023-11-21 |
| Classified | 2024-02-05 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CZ, DE, ES, FR, GB, HR, HU, IE, IL, IT, NL, NZ, PL, PT, SE, SK, TW, ZA |
| Quantity | 128 analyzers |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590732103 |
| Serial numbers | 300116, 300117, 300118, 300123, 300126, 300127, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300140, 300141, 300142, 300143, 300144, 300145, 300146, 300147 and 103 more |
Product
DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
Reason for recall
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or < ) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.
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-0982-2024. 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.