San Diego, CA, US · 1 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | Class II | Microbiology | 1 | 2020-11-09 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2022-04-06 | Class I | Ongoing | Z-1009-2022 | Accula SARS-CoV-2 Test, REF: COV4100 | — | SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2020-11-09 | K201269 | Accula Strep A Test | PGX | Class II | Microbiology |