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iQ200

BECKMAN COULTER IRELAND INC. · Model Select Plus Kit 2008 Analyzer (NA)/ Select Pro (NA) · UDI-DI 10837461001300

KQOLKM Prescription
1
510(k) clearances
1,091
Adverse events (1 deaths)
35
Recalls
68
Facilities

Description

"iQ200 Select 2008 Tested;800-3935 iQ®200 Select Plus Kit 2008 Analyzer (NA) "iQ200 Select 2008 Tested; 800-3051 iQ®200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)"

Recalls

DateFirmReason
2026-08-12Beckman Coulter, Inc.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 replace
2026-08-12Beckman Coulter, Inc.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 replace
2023-04-05Beckman Coulter, Inc.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
2023-04-05Beckman Coulter, Inc.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 be
2023-04-05Beckman Coulter, Inc.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
2023-04-05Beckman Coulter, Inc.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
2021-10-18Roche Diagnostics Operations, Inc.A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. No interference of Nitrite results was observed at creatinin
2020-03-30Beckman Coulter Inc.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 me
2020-03-30Beckman Coulter Inc.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 mel
2020-02-17Beckman Coulter, Inc.The Leukocyte and Compensation pads were switched on some vials of lot number 7212269M of the iChem VELOCITY Strips.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.