BD MAX¿ VAGINAL PANEL
Received Aug 25, 2022 · Event occurred Aug 1, 2022
Report 3007420875-2022-00046 · MDR key 15294748
Device
Generic name
Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Model number
443712Catalog number
443712
Lot number
2110913
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.¿
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ VAGINAL PANEL THERE WAS DISCREPANT RESULTS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MAX 443712_2110913 DISCREPANT RESULTS.
Additional Manufacturer Narrative
THE ISSUE WAS DETERMINED TO BE AGAINST THE INSTRUMENT AND NOT THE REAGENT. THEREFORE, THIS MDR IS BEING CANCELED.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD MAX¿ VAGINAL PANEL THERE WAS DISCREPANT RESULTS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6) DISCREPANT RESULTS.