KIT BDMAX SARS-COV-2 REAGENTS Adverse Event — Malfunction (MDR 3007420875-2020-00001)
KIT BDMAX SARS-COV-2 REAGENTS Adverse Event — Malfunction (MDR 3007420875-2020-00001) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: KIT BDMAX SARS-COV-2 REAGENTS; Generic name: SARS-COV-2 REAGENT KIT; Manufacturer: BECTON, DICKINSON & CO..
| Device | KIT BDMAX SARS-COV-2 REAGENTS |
|---|---|
| Generic name | SARS-COV-2 REAGENT KIT |
| Manufacturer | BECTON, DICKINSON & CO. |
| Report number | 3007420875-2020-00001 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | OTHER, USER FACILITY |
| Narrative | IT WAS REPORTED THAT WHILE USING BD SARS-COV-2 REAGENTS FOR BD MAX¿ SYSTEM A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FALSE POSITIVE RESULTS IN THE SARS COV 2 ASSAY. IN RUN 1627, OUT OF 24, 13 WERE FALSE POSITIVE A1 TO A12 AND B5.". |
| Source | openFDA MAUDE (device adverse events) |
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