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Diagnostic Hybrids Recalls
8 recalls on record · February 13, 2013 to May 16, 2018 · Medical Devices
Recalls by year
13
15
18
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 16, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in se
Hazard: There is a possibility of low volume and/or leaking standard bottles.
May 2, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone
Hazard: There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.
May 2, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in
Hazard: A component of the kit was found to contain bacterial contamination.
May 2, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation
Hazard: A component of the kit was found to contain bacterial contamination.
May 2, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in hum
Hazard: A component of the kit was found to contain bacterial contamination.
May 2, 2018Medical DevicesFDA
Diagnostic Hybrids, Inc. recalls MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human seru
Hazard: There is a potential for the slope of the standard curve to fail to meet the assay validation requirements for the assay.
September 9, 2015Medical DevicesFDA
Diagnostic Hybrids Inc recalls MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnosti
Hazard: Samples are quantitating incorrectly, with approximately 50% higher concentration values than previously reported and historically documented.
February 13, 2013Medical DevicesFDA
Diagnostic Hybrids Inc recalls Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivati
Hazard: RhMK product fungal contamination.