FACSCount 337858Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903378586), received between Mar 18, 2019 and Apr 1, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD FACSCOUNT¿ INSTRUMENT SYSTEM BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. USER IMPACT WAS NOT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE IN WASTE CONNECTOR. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11602808 ↗
• MalfunctionJan 13, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED WHILE USING BD FACSCOUNT" INSTRUMENT SYSTEM BIOHAZARD LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORTED USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE UNDERNEATH INSTRUMENT. WAS THERE SPRAY OF FLUID UNDER PRESSURE? THE LIQUID THAT SPRAYED WAS MIXTURE OF FACSFLOW SHEATH FLUID AND CD4 SAMPLE PREPARATION I.E HIV PATIENT BLOOD MIXED WITH CD4 REAGENT. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN." (B)(6) 2020 IST FROM TASK 1918888 WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? NOT YET ESTABLISHED. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NOT YET ESTABLISHED. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11165979 ↗
• MalfunctionOct 30, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE WASTE TANK LINE WAS LEAKING WITH A BD FACSCOUNT¿ INSTRUMENT SYSTEM. THERE WAS NO REPORT OF ANY HARM TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN WASTE CONNECTOR WAS THE WASTE LEAK MIXED WITH BLEACH OR DECONTAMINANT? R. NO WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? R. NOT CONTAINED WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? R. YES WAS THERE SPRAY OF FLUID UNDER PRESSURE? R. NO WHAT WAS THE FLUID THAT LEAKED? R. BIOHAZARD WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? R. WASTE LINE WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? R. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10766216 ↗
• MalfunctionOct 27, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSCOUNT¿ INSTRUMENT SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE HAS BEEN REPORTED BY THE USER. 1.WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, THE LIQUID WAS DRIPPING OUT OF THE INSTRUMENT. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES, THE CUSTOMER COULD WIPE PUT THE DRIPPING LIQUID FROM THE SURFACE OF THE INSTRUMENT BENCH. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO, THERE WAS NO SPRAYING; ONLY DROPLETS UNDER LOW PRESSURE. 4. WHAT WAS THE FLUID THAT LEAKED? WASTE FLUID. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? FROM THE WORN OUT VACUUM PUMP ALONG THE WASTE LINE. 6.IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? NO, IT WAS NOT. WHILE IT WAS FLOWING IN THE WASTE LINE TUBING AND THE FLUID ONLY GOT INTO CONTACT WITH BLEACH WHEN IT ENDED UP IN THE WASTE TANK FILLED WITH THE BLEACH SOLUTION. USERS CONFIRMED THEY WEAR PPES ALWAYS. 7. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO, THE CUSTOMER WORN PROTECTIVE EQUIPMENT WHEN HANDLING THE INSTRUMENT AND LEAKING FLUID. 8. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER A

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10740622 ↗
• MalfunctionAug 10, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT WITH A BD FACSCOUNT¿ INSTRUMENT SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING WASTE BULKHEAD CONNECTOR. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, SOME FLUID MAY HAVE SPILLED ONTO THE BENCH WHERE INSTRUMENT IS PLACED. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES, IT WAS IN THE FLUIDICS COMPARTMENT WHERE USER ACCESSES TO FILL THE SHEATH AND EMPTY THE WASTE. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? WASTE FROM CD4 SAMPLES AND CLEANING SOLUTIONS. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO, THE CUSTOMER STOPPED USING THE INSTRUMENT IMMEDIATELY THEY DISCOVERED THE LEAKAGE. ALSO, THE CUSTOMER IS USING GLOVES WHEN WORKING ON THE INSTRUMENT. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.¿

  Patient problems: No Patient Involvement

  MAUDE report 10385902 ↗
• InjuryMar 18, 2019Display or Visual Feedback Problem; Use of Device Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT WHILE USING A BD FACSCOUNT INSTRUMENT SYSTEM THE INSTRUMENT WENT INTO AN ERROR STATE THAT PREVENTED SAMPLES FROM BEING PROCESSED. THE INABILITY TO PROCESS SAMPLES RESULTED IN SPECIMENS BEING LEFT AT ROOM TEMPURATURE FOR A PERIOD OF MORE THAN 48 HOURS. A BD FIELD SERVICE ENGINEER NOTED THAT THE FIXATIVE BOTTLES USED BY THE LAB WAS NOT REFRIGERATED AND LAB STAFF INDICATED THE BOTTLES HAD BEEN UNREFRIGERATED FOR AT LEAST TWO DAYS. ADDITIONALLY, ONE OF THE THREE BOTTLES OF FIXITIVE IN USE BY THE LAB WAS NOTED TO HAVE BEEN IN USE PAST THE EXPIRATION DATE. IT WAS REPORTED THAT PATIENTS REQUIRED BLOOD SAMPLES TO BE REDRAWN TO REPEAT PREVIOUSLY ORDERED BLOOD TESTS. 70 BLOOD SAMPLES WERE INVOLVED. THE NUMBER OF PATIENTS OR THE SPECIFIC TESTS WERE NOT SPECIFIED. THERE WAS NO INDICATION OF A CHANGE IN COURSE OF PATIENT TREATMENT OR A DETERIORATION IN PATIENT CONDITION FOR ANY OF THE PATIENTS AS A RESULTS OF DELAYED TEST RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8428935 ↗