BD MAX¿ CDIFF (US)
Received Apr 2, 2026 · Event occurred Mar 5, 2026
Report 3007420875-2026-00073 · MDR key 24766459
Device
Generic name
C.difficile Toxin Gene Amplification Assay
Manufacturer
Geneohm Sciences Canada, Inc. (bd Diagnostics)Catalog number
442555
Lot number
5142231
Product problems
- False Positive Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CDIFF (US), A FALSE POSITIVE PATIENT RESULTS WITH UNUSUAL PCR CURVES WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
E.1. INITIAL REPORTER PHONE NUMBER: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF BD MAX¿ CDIFF (US), A FALSE POSITIVE PATIENT RESULTS WITH UNUSUAL PCR CURVES WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT.
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT (3007420875-2026-00073) SHOULD BE CANCELED BECAUSE IT IS A DUPLICATE OF THE FOLLOWING REPORTS: 1119779-2026-00812, 1119779-2026-00813, 1119779-2026-00814, 1119779-2026-00815, 1119779-2026-00816.