Access Ultrasensitive Insulin only used on the DxI 9000 Access… — Class II medical device recall Z-0981-2024
Ongoing recall by Beckman Coulter, Inc., reported 2024-02-14, distributed nationwide. There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 A
| Recall number | Z-0981-2024 |
|---|---|
| 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 | 19,125 reagent |
| Reason classes | potency |
| UPC / GTIN / UDI-DI | 15099590230623 |
| Lot numbers | 125533, 125589, 233656, 233919, 234055, 234339, 234388 |
| Model numbers | 33410 |
Product
Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Reason for recall
There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
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-0981-2024. 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.