Access 2 Immunoassay System — Class II medical device recall Z-1956-2016
Terminated recall by Beckman Coulter Inc., reported 2016-06-22. Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case
| Recall number | Z-1956-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2016-05-17 |
| Classified | 2016-06-13 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2016-08-26 |
| Countries outside the US | MA, VE |
| Serial numbers | 501368, 504231, 504805, 505143 |
| Model numbers | 386220 |
Product
Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
Reason for recall
Due to the lack of updated thermal components, these instruments may be more susceptible to the internal case temperature exceeding the 18 to 36 degrees Celsius operating range, causing SYS flags. The instrument will not report results until the internal case temperature returns to the operating range. This situation may cause a delay in the reporting of 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-1956-2016. 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.