Iq 200 System

• 2 recalls, same reason

  • Ongoing Z-0160-2027 FDA Not yet classified ·initiated 12 Aug 2026 ·on shared 510(k) K022774
  • Ongoing Z-0161-2027 FDA Not yet classified ·initiated 12 Aug 2026 ·on shared 510(k) K022774

  The rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage; however, the check valve replacement was excluded from the annual preventive maintenance (PM) requirements without adequate reliability evaluation. When the check valve is not replaced annually, it may allow lamina fluid to migrate internally and leak onto the table or floor, potentially resulting in exposure to physical hazards (slip/fall), chemical hazards (lamina fluid exposure), biohazardous exposure, property damage, and delayed patient results.

• 4 recalls, same reason

  • Ongoing Z-0784-2024 FDA Class II ·initiated 19 Dec 2023
  • Ongoing Z-0785-2024 FDA Class II ·initiated 19 Dec 2023
  • Ongoing Z-0786-2024 FDA Class II ·initiated 19 Dec 2023
  • Ongoing Z-0787-2024 FDA Class II ·initiated 19 Dec 2023

  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.

• 3 recalls, same reason

  • Ongoing Z-1599-2023 FDA Class II ·initiated 5 Apr 2023 ·on shared 510(k) K022774
  • Ongoing Z-1597-2023 FDA Class II ·initiated 5 Apr 2023 ·on shared 510(k) K022774
  • Ongoing Z-1598-2023 FDA Class II ·initiated 5 Apr 2023 ·on shared 510(k) K022774

  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.

• • Ongoing Z-1596-2023 FDA Class II ·initiated 5 Apr 2023 ·on shared 510(k) K022774

  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.

• • Terminated Z-1945-2020 FDA Class II ·initiated 30 Mar 2020 ·on shared 510(k) K022774

  A defect in the SATA power adapter cable within the instrument s computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computer s metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the device s CD-ROM.

• • Terminated Z-0914-2020 FDA Class II ·initiated 28 Oct 2019

  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).

• • Terminated Z-1362-2018 FDA Class II ·initiated 2 Mar 2018 ·on shared 510(k) K022774

  Beckman Coulter has determined that there is a potential for under-reporting casts. This can occur if per high-power field (/HPF) units of measurement for casts are selected in the iQ200 software, but the abnormal threshold and/or grading format is set up based on reporting per low-power field (/LPF)* or *per microliter. This may occur during initial method validation or if settings are altered after the initial validation.

• • Terminated Z-1366-2018 FDA Class II ·initiated 10 Nov 2017 ·on shared 510(k) K022774

  iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay treatment for health conditions such as hematuria.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K022774 ↗

FDA Product Code

LKM

Device Class

Class II

Regulation

21 CFR Part 864.5200

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Iris Urine Stain

  Class I

  FDA 510(k) K821503 Active Cleared 3 Jun 1982

• 939UDX Urine Pathology System

  Class II

  FDA 510(k) K000373 Active Cleared 14 Apr 2000

• The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis Capability

  Class II

  FDA 510(k) K934539 Active Cleared 30 Mar 1994

• Iristain Formula 2, Parts 1 and 2

  Class I

  FDA 510(k) K893530 Active Cleared 13 Jun 1989

• Yellow Iris Urinalysis Wrksta W/Iriscope Bdy Flu

  Class II

  FDA 510(k) K914256 Active Cleared 1 May 1992

• The Yellow Iris Urinalysis Workstation

  Class I

  FDA 510(k) K972141 Active Cleared 25 Aug 1997

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