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Hycor Biomedical Recalls
3 recalls on record · August 7, 2019 to November 6, 2019 · Medical Devices
November 6, 2019Medical DevicesFDA
Hycor Biomedical LLC recalls HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or a
Hazard: Some of the Stop Solution bottles, a caustic solution, have been reported to leak.
August 14, 2019Medical DevicesFDA
Hycor Biomedical Inc recalls HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only. HYTEC
Hazard: Reports when using Rheumatoid Factor test kits, control and negative samples may be elevated following a sample containing high levels of IgG . The negative control may report out of range; a negative sample may recover as a low positive which could contribute to an incorrect or premature diagnosis of rheumatoid.
August 7, 2019Medical DevicesFDA
Hycor Biomedical Inc recalls AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05 Product Usage: Rheumatoid Factor IgM ELISA is intended to be ut
Hazard: Reports of higher than anticipated positivity rate for patients tested using IgM Kit. Some negative samples may be reported as positive for IgM antibodies to Rheumatoid Factor.