Access 2 Immunoassay System — Class III medical device recall Z-0308-2018
Terminated recall by Beckman Coulter Inc., reported 2018-01-10, distributed in GA. Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performin
| Recall number | Z-0308-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beckman Coulter Inc., Brea, CA, United States |
| Recall initiated | 2017-11-06 |
| Classified | 2018-01-03 |
| Reported by FDA | 2018-01-10 |
| Terminated | 2019-11-04 |
| Distributed | GA |
| Countries outside the US | AR, CA, CL, CN, CR, DE, FR, GB, GH, GR, HK, IN, IT, JP, KR, MA, MX, NP, PH, PL, RU, SA, SK, TH, TR, VN, ZA |
| Quantity | 227 units |
| Lot numbers | 512684, 570005-570043, 570047-570049, 570051-570061, 570066-570071, 570073-570091, 570093-570123, 570125, 570126, 570128, 570131-570153, 570156-570203, 570205-570241, 570244-570248, 570250-570252 |
| Model numbers | 81600N |
Product
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason for recall
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
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-0308-2018. 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.