Recall Z-1670-2021— Beckman Coulter Inc.
Class II · Terminated
Class II FDA medical device recall by Beckman Coulter Inc., initiated 2021-04-14, terminated 2023-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e. Reason: specimens collected in transport media may result is false negative results when stored in certain conditions..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-14
- Terminated
- 2023-05-19
- Firm location
- Brea, CA, United States
Product description
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
Reason for recall
specimens collected in transport media may result is false negative results when stored in certain conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.