iChem Velocity Back-Integrated Velocity (NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10837461001751), received between Oct 5, 2016 and Jul 12, 2023 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (5 reports).

1 FDA recall record name this device's identifier.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Oct 28, 2019Class IITerminated

   Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and different patient identification (demographics).

   Z-0913-2020 · Root cause: Software in the Use Environment · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN (13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE (B)(6) SHOWED >100,000 E COLI AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 24 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17307940 ↗
• InjuryJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN (13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE 122316401328 SHOWED 50,00-100,000 STAPHYLOCOCCUS AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 24 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17307570 ↗
• InjuryJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN (13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE 122316401045 SHOWED 50,000-100,000 CFU E COLI AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 72 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17307070 ↗
• InjuryJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN (13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE (B)(6) SHOWED 100,000 CFU PSEUDOMONAS AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 24 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17306254 ↗
• InjuryJul 12, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED FALSE NEGATIVE ERRONEOUS RESULTS FOR URINE SAMPLES RUN ON THEIR ICHEM VELOCITY URINE CHEMISTRY ANALYZER. NO FLAGS WERE GENERATED BY INSTRUMENT. THIRTEEN(13) PATIENT RESULTS WERE CONSIDERED TO BE IN QUESTION AND THE CUSTOMER BEGAN URINE CULTURES FOR THEM. THE ORIGINAL SAMPLES THAT HAD BEEN REFRIGERATED WERE RE-RUN WITHIN 24 HOURS. THE CULTURE RESULTS FOR SAMPLE 122316400979 SHOWED MIXED FLORA POSSIBLE CONTAMINATION AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS WITHIN 24 HOURS FROM THE TIME THE ORIGINAL URINALYSIS COLLECTION TOOK PLACE. THERE WERE ANOTHER FIVE (5) PATIENTS THAT REQUIRED ANTIBIOTICS, ONE OF WHICH WAS PRESCRIBED ANTIBIOTICS FOR BACTEREMIA/SEPSIS PRIOR TO THE URINE CULTURE BEING PROCESSED. INDIVIDUAL REPORTS WILL BE FILED FOR THE OTHER FOUR (4) PATIENTS AND WILL BE REFERENCED AS RELATED EVENTS IN SECTION H10. THERE WAS NO ADVERSE EVENT REPORTED FOR ANY OF THE 5 PATIENTS THAT WERE DELAYED IN HAVING ANTIBIOTICS PRESCRIBED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17305876 ↗
• MalfunctionJul 28, 2021Fire; Fire

  THE CUSTOMER REPORTED A BURNING SMELL COMING FROM THEIR ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM. THERE WAS NO INJURY REPORTED, THE FIRE DEPARTMENT WAS NOT CALLED, NO EVACUATION OF THE LAB OCCURRED, AND NO ERRONEOUS RESULTS WERE GENERATED DURING THE EVENT. THE FIELD SERVICE ENGINEER (FSE) WAS ONSITE AND WHILE TROUBLESHOOTING THE INSTRUMENT, FOUND EVIDENCE THAT A FIRE HAD TAKEN PLACE WITHIN THE INSTRUMENT. THE FIRE OCCURRED IN THE AIR GAP HARNESS, MELTING THE WIRE CONNECTORS AND ZIP TIES THAT HOLD IT IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243122 ↗
• MalfunctionOct 14, 2019Fire; Fire

  THE CUSTOMER REPORTED THAT WAS A FIRE IN THE COMPUTER TOWER FOR THEIR IRICELL SYSTEM. THE IRICELL IS COMPOSED OF AN ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM AND AN IQ 200 URINE ANALYZER. ON 16-SEP-2019, THE CUSTOMER CALLED CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT THAT THEIR IRICELL SYSTEM PC6 COMPUTER CAUGHT FIRE AND THE FIRE DEPARTMENT WAS CALLED. THE PC6 IS USED FOR BOTH THE ICHEM VELOCITY AND IQ200 INSTRUMENTS. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY TO ANY LABORATORY PERSONNEL AND THAT THE LAB DID NOT SUFFER ANY DAMAGE AS A RESULT OF THE ALLEGED FIRE. THE CUSTOMER STATED TO THE FIELD SERVICE ENGINEER (FSE) THAT THE PC6 HAD CAUGHT FIRE INTERNALLY AND THAT IT WAS BLOWING SPARKS/FIRE OUT OF THE FANS AND VENTS AND THAT THERE WAS NO DAMAGE OBSERVED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188461 ↗
• MalfunctionAug 22, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE CUSTOMER REPORTED AN EXPOSED WIRE ABOVE THE PROBE ON AN ICHEMVELOCITY SYSTEM. THE CUSTOMER SAW A PUFF OF SMOKE AND REPORTED A CHARRED AREA ON THE INSTRUMENT. THE CUSTOMER INFORMED THE CUSTOMER TECHNICAL SPECIALIST (CTS) THAT THEY ATTEMPTED TO PERFORM THEIR OWN TROUBLESHOOTING. THE CUSTOMER REPORTED ON THE INITIAL CALL THAT THERE WERE NO INJURIES. THE FIELD SERVICE ENGINEER (FSE) DOCUMENTED IN THE SERVICE RECORD THAT THE CUSTOMER FURTHER REPORTED THAT A GROUND WIRE ON THE PIPETTE BRACKET ASSEMBLY MELTED HER GLOVE AND BURNED HER FINGER. IT IS UNKNOWN AT THIS TIME WHETHER THE CUSTOMER REQUIRED MEDICAL TREATMENT FOR THE BURN.

  Patient problems: Burn(s)

  MAUDE report 8923233 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE CUSTOMER HAS REPORTED THAT ONE OF THEIR OPERATORS IS SUFFERING FROM A SKIN RASH AND UPPER RESPIRATORY COMPLICATIONS THAT BEGAN SHORTLY AFTER BEGINNING TO OPERATE THEIR ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM. THE OPERATOR DID SEEK MEDICAL TREATMENT. THE CUSTOMER ALSO STATED THAT THERE HAVE BEEN OTHER OPERATORS AFFECTED IN THE PAST.

  Patient problems: Chemical Exposure

  MAUDE report 8746573 ↗
• MalfunctionApr 10, 2019Fire; Fire

  THE CUSTOMER REPORTED THAT WAS A FIRE IN THE COMPUTER TOWER FOR THEIR IRICELL SYSTEM. THE IRICELL IS COMPOSED OF AN ICHEM® VELOCITY¿ AUTOMATED URINE CHEMISTRY SYSTEM AND AN IQ 200 URINE ANALYZER. ON (B)(6) 2019, THE CUSTOMER CALLED CUSTOMER TECHNICAL SUPPORT (CTS) TO REPORT THAT THEIR IRICELL SYSTEM PC6 COMPUTER CAUGHT FIRE. THE PC6 IS USED FOR BOTH THE ICHEM VELOCITY AND IQ200 INSTRUMENTS. THE CUSTOMER STATED THAT THERE WERE NO NOISES COMING FROM THE PERSONAL COMPUTER (PC) PRIOR TO IT CATCHING FIRE,THAT THEY OBSERVED ACTUAL FLAMES COMING FROM THE PC, AND THAT THEY UNPLUGGED THE COMPUTER, PLACED IT ON THE FLOOR, AND USING WATER, PUT OUT THE FIRE. THE FIRE DEPARTMENT WENT ON-SITE, INSPECTED THE AREA, AND DECLARED IT SAFE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH OR ATTRIBUTED TO THIS EVENT. THERE WAS NO DIRECT EXPOSURE TO SMOKE OR FLAMES REPORTED. NO PATIENT¿S RESULTS WERE AFFECTED, AS NONE WERE RUNNING AT THE TIME OF THE INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8501036 ↗
• InjuryDec 1, 2018Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE DRAIN HOSE (DRAIN TUBING) DISLODGED (POPPED-OFF) FROM THE RIGHT SIDE OF THEIR ICHEMVELOCITY AUTOMATED URINE CHEMISTRY SYSTEM AND SPRAYED APPROXIMATELY 20 MILLILITERS (ML) OF A PRESSURIZED FLUID WHICH THE CUSTOMER STATES WAS A CLEAR REAGENT AND WASTE MATERIAL. THE CUSTOMER NOTICED THAT THE DRAIN TUBING CONTINUED TO POP-OFF OF THEIR INSTRUMENT. WHEN THE DRAIN TUBING BECAME DISCONNECTED, THE CUSTOMER STATED THAT THERE WAS FLUID THAT SPRAYED FROM THE DRAIN TUBING. THE LIQUID FROM THE DRAIN TUBING WAS REPORTED TO HAVE SPRAYED ONTO THE CUSTOMER CAUSING THE LIQUID TO COME INTO DIRECT CONTACT WITH THE EYES, NOSE, MOUTH, CLOTHING AND HANDS. THE CUSTOMER TECHNICAL SUPPORT SPECIALIST (CTS) THERE WAS DIRECT EXPOSURE TO OPEN WOUNDS AND/OR MUCOUS MEMBRANES THAT RESULTED WITH THE CUSTOMER SEEKING MEDICAL ATTENTION. THE CUSTOMER DID HAVE PERSONAL PROTECTIVE EQUIPMENT (PPE) WHICH CONSISTED OF GLOVES, LABORATORY COAT AND EYE PROTECTION AT THE TIME OF THE EVENT. THERE WERE NO ERRONEOUS RESULTS THAT WERE GENERATED OR REPORTED OUTSIDE OF THE CUSTOMER¿S LABORATORY AS A RESULT OF THIS EVENT.

  Patient problems: Exposure to Body Fluids; No Patient Involvement

  MAUDE report 8122592 ↗
• MalfunctionDec 7, 2017Computer Software Problem; Computer Software Problem

  ON (B)(6) 2017, THE CUSTOMER CONTACTED BECKMAN COULTER ADVISING THAT THEY FAILED THE CAP SURVEY FOR PH RESULTS ON THEIR ICHEMVELOCITY INSTRUMENT. A FIELD SERVICE ENGINEER (FSE) WAS ON SITE THE SAME DAY ((B)(6) 2017) TO INVESTIGATE THE CAP SURVEY FAILURE. THE FSE'S ASSESSMENT OF THE INSTRUMENT CONCLUDED THAT THE SOFTWARE INSTALLED ON THE INSTRUMENT WAS CONFIGURED TO THE INTERNATIONAL SETTINGS, NOT THE REQUIRED NORTH AMERICAN CONFIGURATION OF THE SOFTWARE. DURING THE TIME SINCE THE DATE OF EVENT ((B)(6) 2017), THE CUSTOMER WAS RUNNING WITH TEST STRIPS THAT ARE USED WITH THE NORTH AMERICAN CONFIGURATION OF THE INSTRUMENT. USE OF INTERNATIONAL SETTINGS WITH THE NORTH AMERICAN STRIPS DOES NOT YIELD CORRECT RESULTS AND BEC CONTINUES TO INVESTIGATE TO DETERMINE WHETHER THERE WAS ANY PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7095873 ↗
• MalfunctionNov 2, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED THAT GLUCOSE WAS FAILING FALSE NEGATIVE FOR CA CONTROL ON THEIR ICHEM VELOCITY URINE CHEMISTRY SYSTEM. THERE WERE NO REPORTS OF ERRONEOUS PATIENT RESULTS BEING GENERATED OR REPORTED OUT AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6074865 ↗
• MalfunctionOct 31, 2016Fluid/Blood Leak; Device Operates Differently Than Expected; Fluid/Blood Leak; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED A CONTAINED LEAK ON THEIR ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM. THE CUSTOMER ALSO STATED THEY WERE EXPERIENCING CHEM NA AND SHORT SAMPLE ERRORS ON ALL PATIENT SAMPLES AND CONTROLS. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME THE LEAK WAS OBSERVED. THERE WERE NO REPORTS OF EXPOSURE TO OPEN WOUND OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6068431 ↗
• MalfunctionOct 5, 2016Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATED THAT THERE WAS A CONTAINED FLUID LEAK OF APPROXIMATELY 7ML FROM THE PROBE ON AN ICHEMVELOCITY AUTOMATED URINE CHEMISTRY SYSTEM. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF THE EVENT AND THERE WAS NO REPORT OF INJURY OR BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO INJURY OR EFFECT TO PATIENT TREATMENT RELATED TO THIS EVENT.

  Patient problems: Not Applicable

  MAUDE report 6000859 ↗