FDA Device recall Z-2255-2021
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713 by Beckman Coulter, citing SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2255-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-01 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
ACCESS SARS-CoV-2 Antigen , REF: C68668, IVD, Rx only, UDI: (01) 15099590742713;
Reason
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2255-2021%22
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