iQ200 Elite Plus (US) (2008 Version) (NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10837461001355), received between Aug 25, 2017 and Nov 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fire” (1 report).

3 FDA recall records name this device's identifier, 2 still open.

9 other recalls cover devices cleared under the same FDA submission (K022774); they may or may not involve this specific model.

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 16, 2026.

Recalls naming this device

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 · 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 · 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022774. One submission often covers many models, so check the product and lot details in each record.

• Z-0787-2024 · Dec 19, 2023 · Open, Classified
  iQ Waste Well Adapter, Part Number: 700-3393
• Z-0784-2024 · Dec 19, 2023 · Open, Classified
  Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947
• Z-0786-2024 · Dec 19, 2023 · Open, Classified
  REV 2 Flowcell Capsule Spare, Part Number: C04154
• Z-1598-2023 · Apr 5, 2023 · Open, Classified
  DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis
• Z-1599-2023 · Apr 5, 2023 · Open, Classified
  UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis
• Z-1597-2023 · Apr 5, 2023 · Open, Classified
  DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
• Z-1945-2020 · Mar 30, 2020 · Terminated
  iQ200 Series Urine Microscopy Analyzer- All part numbers
• Z-1362-2018 · Mar 2, 2018 · Terminated
  BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer, Catalog Numbers: 700-3345, C10684, 700-3375, C10683, 700-3325, 700-3347, 700-3320, 700-3322, 700-3370
• Z-1366-2018 · Nov 10, 2017 · Terminated
  iQ200 Series Urine Microscopy Analyzer with Barcode Reader Model NFT-2100, Catalog #s: 800-3046, 800-3047, 800-3052, 800-3053, 800-3802, 800-3803, 800-3900, 800-3920, 800-3925, 800