DxA 5000 — Class II medical device recall Z-2602-2021
Terminated recall by Beckman Coulter Inc., reported 2021-10-06, distributed nationwide. There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport sa
| Recall number | Z-2602-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2021-07-21 |
| Classified | 2021-09-30 |
| Reported by FDA | 2021-10-06 |
| Terminated | 2024-10-10 |
| Distributed | Nationwide (US) |
| Quantity | 123 systems |
| Reason classes | microbial contamination |
| UPC / GTIN / UDI-DI | 15099590707118 |
| Serial numbers | T23000038, T23000039, T23000040, T23000045, T23000062, T23000063, T23000064, T23000065, T23000066, T23000069, T23000070, T23000074, T23000075, T23000076, T23000077, T23000080, T23000081, T23000082, T23000083, T23000084, T23000085, T23000090, T23000091, T23000092, T23000093 and 51 more |
Product
DxA 5000 (DxA Automation System, DxA 5000 fit), "For in Vitro Diagnostic Use", Reference Numbers: B87352 with B57634, UDI: 15099590707118
Reason for recall
There is a potential that sample carriers (w or w/o samples) within automated sampling system may transport samples to the outer lane which does not contain a physical barrier to restrain samples. Samples are dropped when they reach the end of the outer lane which could result in Delay in providing patient with appropriate medical treatment. New sample needs to be drawn. Substantial discharge of biohazards material - Infection with a human transmissible blood-borne or animal pathogen which could result in Infection with a human transmissible blood-borne pathogen (e.g. infectious HBV, HCV, HIV).
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-2602-2021. 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.