BD FACSLYRIC¿ FLOW CYTOMETER
Received Aug 8, 2025 · Event occurred Jul 16, 2025
Report 3027394506-2025-00035 · MDR key 22757673
Device
Generic name
Flow Cytometric Reagents And Access.
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
651165
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT WAS SENT IN ERROR. WE HAVE CONFIRMED THAT CARRYOVER WAS NOT OBTAINED ON PATIENT SAMPLES, THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OF PATIENT SAMPLES OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION IN THE H2O TUBES OF THE MANUAL PORT
Additional Manufacturer Narrative
H.3. 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 WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER OF PATIENT SAMPLES OCCURRED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION IN THE H2O TUBES OF THE MANUAL PORT.