FDA Device recall Z-0309-2018
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220
- FDA Device
- Class III
- terminated
- Published 2018-01-10
On 2018-01-10 the FDA classified a Class III recall of Access 2 Immunoassay System, Remanufactured, Catalog Number 386220 by Beckman Coulter, citing potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0309-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-11-06 |
| Published | 2018-01-10 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | GA |
Product
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Reason
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Identifiers
| code_info | Serial/Lot Numbers: 507114, 503299 and 508111 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2018%22
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