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OSOM Ultra Flu Aspirate 25T Kit
SEKISUI DIAGNOSTICS, LLC · Model 1007 · UDI-DI 00742860100239
PSZ
Prescription
10
510(k) clearances
169
Adverse events (3 deaths)
5
Recalls
38
Facilities
Description
OSOM Ultra Flu Aspirate 25T Kit
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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