Automated Urinalysis System

iQ200 Series Urine Microscopy Analyzer: a) iQ 200 Select, Part Numbers C10684 and 700-3345; b) iQ 200 Elite, Part Numbers C10683 and 700-3375; in-vitro diagno

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.

DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis

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.

DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

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.

UA WIN 10 Kit, Catalog Number C52900, in-vitro diagnostic device, urine analysis

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.

iChemVELOCITY Urine Chemistry System-

A defect in the SATA power adapter cable within the instruments 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 computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.

iQ200 Series Urine Microscopy Analyzer- All part numbers

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.

iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001.

The Strip Provider Modules (SPM) on some of the instruments had not been inspected during manufacture for correct seal placement and integrity.

iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166,

The probe misalignment or bending has the potential to lead to delay in reporting results or incorrect patient results.

iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720.

Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling.

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.