FDA Device recall Z-2258-2021
ACCESS SARS-CoV-2 ANTIGEN EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
- 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 EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017 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-2258-2021 |
| 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 EXTRACTION SOLUTION, CONTENTS: 6 x 6.0 mL EXTRACTION SOLN, IVD, Rx Only, UDI: (01)15099590743017
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-2258-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.