iQ200 Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10837461001300), received between Aug 6, 2021 and Oct 12, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 reports).

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

10 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 18, 2026.

Recalls naming this device

1. Dec 19, 2023Class IIOpen, 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, 2023Class IIOpen, 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 ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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-0914-2020 · Oct 28, 2019 · Terminated
  iQ200 Series Urine Microscopy Analyzer, Catalog numbers: 700-3345, 700-3375, 700-3325, 700-3347, 700-3300RFB, 700- 3320, 700-3320RFB, 700-3322, 700-3322RFB, 700-3326, 700- 3340, 7
• 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