Access 2 Reaction Vessels — Class II medical device recall Z-0889-2026
Ongoing recall by Beckman Coulter, Inc., reported 2025-12-17, distributed nationwide. It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. T
| Recall number | Z-0889-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter, Inc., Chaska, MN, United States |
| Recall initiated | 2025-11-07 |
| Classified | 2025-12-09 |
| Reported by FDA | 2025-12-17 |
| Distributed | Nationwide (US) |
| Quantity | 38,225 untis |
| UPC / GTIN / UDI-DI | 15099590180249 |
| Lot numbers | P243943, P243971, P244202, P244344, P244345, P250001, P250002, P250003, P250004, P250005 |
| Model numbers | 81901 |
Product
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901
Reason for recall
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
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-0889-2026. 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.