BD FACSLYRIC¿
Received Dec 3, 2025 · Event occurred Nov 20, 2025
Report 3027394506-2025-00046 · MDR key 23708918
Device
Generic name
Flow Cytometric Reagents And Accessories
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
663029
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING 'SIT FLUSH WORKING INTERMITTENTLY' WAS DUE TO PUMP 1 AND SUCTION PUMP. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND, MANUFACTURING DEFECT TREND, DEVICE HISTORY RECORD (DHR) AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING SIT FLUSH WORKING INTERMITTENTLY WAS DUE TO PUMP 1 AND SUCTION PUMP. PARTS WERE REPLACED, AND THE FIRMWARE WAS UPGRADED TO 1.1.198. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE BD FACSLYRIC¿, CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. SIT FLUSH DOES NOT WORK SOMETIMES. CARRYOVER BETWEEN PATIENT SAMPLES. CUSTOMER REPORTED THAT SOMETIMES CARRYOVER OCCURRED, BUT NO RESULTS WERE RELEASED FROM THOSE SAMPLES.
Additional Manufacturer Narrative
G.5. THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. 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 OF THE BD FACSLYRIC¿, CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. SIT FLUSH DOES NOT WORK SOMETIMES. CARRYOVER BETWEEN PATIENT SAMPLES. CUSTOMER REPORTED THAT SOMETIMES CARRYOVER OCCURRED, BUT NO RESULTS WERE RELEASED FROM THOSE SAMPLES.