INNOVITA
Innovita (Tangshan) Biological Technology Co., Ltd. · Model YF335C155 · UDI-DI 06970640093097
Description
The Innovita Flu A/B Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection and differentiation of influenza A and B viral nucleoprotein antigens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the differential diagnosis of acute influenza A and B viral infections. The test is not intended to detect influenza C antigens. Negative test results are presumptive and should be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-05 | Becton Dickinson & Co. | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the i |
| 2020-09-25 | Quidel Corporation | Due to false positive results. |
| 2019-04-03 | Becton Dickinson & Co. | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagn |
| 2019-04-03 | Becton Dickinson & Co. | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagn |
| 2017-12-15 | Quidel Corporation | The calibration for the affected batch of analyzers was incorrectly set during the manufacturing process which may lead to a failure when calibration is first performed. There may |
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