iQ200Recalls & reported problems across all models

We found 4 models of iQ200 by Beckman Coulter Ireland Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2017 and Apr 6, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (4 reports).

3 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

iQ200 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Dec 19, 2023Open, Classified

   Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.

   Z-0785-2024 · Root cause: Other · names 4 of these models · Recall details · FDA record ↗

2. Apr 5, 2023Open, Classified

   Beckman Coulter has become aware of an intermittent issue in which the optional flag Previous Sample Had Sperm was enabled but not displayed so that a carryover event could have been investigated.

   Z-1596-2023 · Root cause: Under Investigation by firm · names 4 of these models · Recall details · FDA record ↗

3. Oct 28, 2019Terminated

   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-0914-2020 · Root cause: Software in the Use Environment · names 3 of these models · Recall details · FDA record ↗

Most reported iQ200 problems

iQ200 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• iQ200 Elite Plus (US) (2008 Version) (NA)

  Automated Urinalysis System
  3 recalls2 reports
• iQ200 Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT Pro w load/unload (NA)/Sprint P

  Automated Urinalysis System
  3 recalls1 report
• iQ200 Select/Elite Pro (NA)

  Automated Urinalysis System
  3 recalls0 reports
• iQ200 Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA)

  Automated Urinalysis System
  2 recalls4 reports

Recent iQ200 adverse event reports

The 7 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 6, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED ERRONEOUS FALSE-NEGATIVE PATIENT CYTOLOGY TEST-RESULTS FROM THEIR IQ200 SPRINT URINALYSIS INSTRUMENT. THE CUSTOMER STATED THAT A CULTURE WAS PERFORMED ON SOME PATIENT SAMPLES WITH FALSE-NEGATIVE CYTOLOGY RESULTS; THE CULTURE REVEALED A VERY HIGH NUMBER OF LEUKOCYTES ON THE QUESTIONED PATIENT SAMPLES. ERRONEOUS PATIENT TEST RESULTS WERE REPORTED OUTSIDE OF THE CUSTOMER¿S LABORATORY. ONE ERRONEOUS PATIENT TEST RESULTED IN THE DELAY OF ANTIBIOTIC TREATMENT FOR 24 HOURS FOR THE PATIENT. THERE WAS NO REPORT OF AN ADVERSE EVENT OCCURRING AS A RESULT OF THE DELAY IN TREATMENT. PATIENT DATA WAS REQUESTED BUT NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Bacterial Infection

  MAUDE report 14026109 ↗
• InjuryOct 12, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED LEUKOCYTES WERE NOT DETECTED ON A URINE SAMPLE ON THE IQ200 INSTRUMENT CAUSING A DELAY IN PATIENT TREATMENT. BASED ON AVAILABLE INFORMATION THERE WAS A DELAY ON PATIENT TREATMENT FOR ONE PATIENT SAMPLE. THERE WAS A 10 TO 12-HOUR DELAY ON PATIENT TREATMENT. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT. ERRONEOUS RESULTS REPORTED: ZERO WBC. CORRECTED RESULT: 197 WBCUL, AND 122 WBCUL. LEUKOCYTES WERE NOT DETECTED ON A HAEMATURIC URINE SAMPLE ON THE IQ200 INSTRUMENT CAUSING A DELAY IN PATIENT TREATMENT. NO BACTERIA DETECTED. THIS ANALYSIS WAS CARRIED OUT ON THE URINE OF A PATIENT ADMITTED TO THE EMERGENCY ROOM BECAUSE HAEMATURIC URINE. DETECTION OF A URINARY INFECTION BY A STRIP TEST WAS PERFORMED. THE CUSTOMER STATED THAT THE URINE HAD BEEN DILUTED TO 1/26TH AS RECOMMENDED BECAUSE IT WAS VERY HAEMATIC. THE SAMPLE WAS THEN DILUTED TO 1/2. THE LEUKOCYTES WERE DETECTED SMALL PARTICLES WERE THEN DETECTED, SO A GRAM STAIN WAS COMPLETED, GRAM-NEGATIVE BACILLI WERE OBSERVED. THE PATIENT RECEIVED ANTIBIOTIC TREATMENT(PHOSPHOMYCIN) FOR A SIMPLE URINARY INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 12619983 ↗
• MalfunctionSep 28, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED DISCORDANT RESULTS ON PURULENT URINE TESTED ON THEIR IQ 200 URINE ANALYZER CAUSING DELAY IN ONE PATIENT'S TREATMENT. THERE WAS A 24-HOUR DELAY IN IDENTIFYING A PYELONEPHRITIS DIAGNOSIS FOR ONE PATIENT CAUSING THE SET UP OF ANTIBIOTIC THERAPY TO BE DELAYED FOR ONE DAY. THE PATIENT RECEIVED AUGMENTIN IV AS TREATMENT. THE AFFECTED PATIENT RESULTS: (B)(6).

  Patient problems: Urinary Tract Infection

  MAUDE report 12544966 ↗
• MalfunctionSep 1, 2021Fire; Electrical Shorting; Fire; Electrical Shorting

  THE CUSTOMER REPORTED THAT THE COMPUTER ON THEIR IQ 200 URINE ANALYZER GENERATED A SPARK AND BLEW THE FUSES OF THE LABORATORY. THE DVD RW'S POWER PLUG WAS BURNT, SHOWING CHARRING AND A MELTED/BURNT CONNECTOR ON THE SATA PORT. THERE WAS NO REPORT OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS EVENT. THERE WAS VISIBLE SMOKE OBSERVED. A FIRE EXTINGUISHER WAS NOT USED. THE FIRE DEPARTMENT WAS NOT CALLED AND THE LAB AS NOT EVACUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12408852 ↗
• InjuryAug 6, 2021Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT WHILE HANDLING THE CLEANSER BOTTLE ON THEIR IQ200 URINE ANALYZER, THE BOTTLE HIT THE COUNTER AND CLEANSER FLUID SPLASHED IN THE OPERATOR'S EYE. THE OPERATOR FOLLOWED UP WITH THEIR ER PHYSICIAN. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE EYE EXPOSURE AND WORKS WITH THE INSTRUMENT AND CLEANER ON A DAILY BASIS. THERE WERE NO ERRONEOUS RESULTS OR PATIENT IMPACT AS A RESULT OF THIS EVENT, THIS WAS AN OPERATOR INJURY. THE PHYSICIAN PRESCRIBED ANTIBIOTICS AS A PREVENTIVE MEASURE AND STATED THERE WAS NO MAJOR INJURY. THE OPERATOR WAS BACK AT WORK THE NEXT DAY WITHOUT ISSUE AND STATED SHE IS DOING FINE.

  Patient problems: Eye Injury

  MAUDE report 12292082 ↗
• MalfunctionNov 1, 2019Fire; Fire

  THE CUSTOMER REPORTED THAT THE CENTRAL PROCESSING UNIT (CPU) ON THEIR IRICELL SYSTEM CAUGHT FIRE. 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 AND SMOKE WAS EMANATING FROM IT. THE CUSTOMER SAW SMOKE COMING FROM THE PC AND PULLED THE FIRE ALARM. THE FIRE DEPARTMENT SHOWED UP AND EVACUATED THE LABORATORY. THE CUSTOMER CONFIRMED THAT THERE WAS NO INJURY TO ANY LABORATORY PERSONNEL AND THAT PATIENT SAMPLES WERE NOT AFFECTED AS A RESULT OF THE ALLEGED FIRE. THERE WAS NO ELECTRICAL HAZARD AS A RESULT OF THIS EVENT. THERE WAS NO EXTERNAL FIRE HAZARD. NO ONE WAS BURNED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9269691 ↗
• MalfunctionAug 25, 2017Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED INITIALLY THAT THEIR IQ200 ELITE REPEATEDLY GAVE ERROR MESSAGES (ALARM CODES 21 AND 22 WHICH WERE ASSOCIATED WITH FBA STATE 44 VALVE ERRORS 0X8) FROM 5 AM TO 5 PM ON (B)(6) 2017. AFTER TROUBLESHOOTING WITH THE CUSTOMER, THE FIELD SERVICE ENGINEER (FSE) ADVISED THE CUSTOMER TO RERUN PREVIOUSLY TESTED SAMPLES. THE CUSTOMER STATED THAT 9 (OUT OF 114 SAMPLES REVIEWED) WERE FOUND TO BE ERRONEOUS (BOTH FALSE POSITIVE AND FALSE NEGATIVE) ON MULTIPLE PARAMETERS (MAINLY WBC, RBC, BACTERIA AND OTHER ANALYTES) AND HAD BEEN REPORTED OUT OF THE LAB. ERRONEOUS PATIENT RESULTS WERE GENERATED AND REPORTED OUT. THE CUSTOMER STATED THAT 1 PATIENT WAS BELIEVED TO HAVE A URINARY TRACT INFECTION AND WAS PRESCRIBED MEDICATION (ANTIBIOTIC) BASED ON THE ERRONEOUS RESULTS (FALSE POSITIVE BACTERIA, WBC AND RBC) REPORTED. THE CUSTOMER INDICATED THAT THE PATIENT CHOSE NOT TO TAKE THE MEDICATION. THERE WERE AN ADDITIONAL 8 PATIENT SAMPLES THAT WERE REPORTED OUT WITH FALSE NEGATIVE ERRONEOUS RESULTS FOR MULTIPLE PARAMETERS (RBC, WBC, BACTERIA). THE RESULTS WERE LATER CORRECTED ON THE SAME DAY. FOUR OF THE SAMPLES HAD THE CULTURE TEST DELAYED (<24 HOURS) BECAUSE THEY WERE INITIALLY REPORTED

  Patient problems: Test Result

  MAUDE report 6822527 ↗

Other Beckman Coulter Ireland Inc. products

• iChem Velocity3 models · 15 reports · 2 recalls