MicroScan autoSCAN-4 Instrument — Class II medical device recall Z-0269-2023
Ongoing recall by Beckman Coulter, Inc., reported 2022-11-30, distributed nationwide. Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
| Recall number | Z-0269-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., West Sacramento, CA, United States |
| Recall initiated | 2022-10-03 |
| Classified | 2022-11-18 |
| Reported by FDA | 2022-11-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE, ES, GB, ID, IE, IT, JP, MX, PE, PT, UY, ZA |
| Quantity | 53 plates |
| UPC / GTIN / UDI-DI | 15099590658625 |
| Model numbers | 5639-0001, B1018-280 |
Product
MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280
Reason for recall
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.
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-0269-2023. 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.