The Recall Desk

Manufacturer

Diagnostic Hybrids, Inc.

8 recalls in our database name Diagnostic Hybrids, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2018-05-16

Of the 8 recalls from Diagnostic Hybrids, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • ModerateFDA (Devices)·Z-1797-2018·2018-05-16

    Diagnostic Hybrids Recalls MicroVue BAP EIA Kits Due to Leaking Bottles

    Diagnostic Hybrids, Inc. is recalling 1004 units of the MicroVue BAP EIA Model 8012 because standard bottles may have low volume or leak.

    Product
    MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1497-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 19 MicroVue CIC-C1q EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. The MicroVue CIC-C1q EIA is for detection of circulating immune complexes (CIC) in human serum or plasma. In certain disease states, immu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1498-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 107 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1496-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns

    Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.

    Product
    MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the dilut
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1499-2018·2018-05-02

    Diagnostic Hybrids Recalls MicroVue SC5b-9 Plus EIA Kits Due to Bacterial Contamination

    Diagnostic Hybrids, Inc. is recalling 72 MicroVue SC5b-9 Plus EIA kits because a component was found to contain bacterial contamination.

    Product
    MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the quantitation of SC5b-9 complex present in human plasma or serum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1520-2018·2018-05-02

    Quidel MicroVue Intact PTH EIA Recalled for Potential Calibration Issues

    Diagnostic Hybrids, Inc. is recalling 26 units of the Quidel MicroVue Intact PTH EIA due to a potential loss of separation between calibrators that may impact assay calibration.

    Product
    Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0417-2015·2015-09-09

    Diagnostic Hybrids Recalls MicroVue Bb Plus EIA Kits Due to Inaccurate Results

    Diagnostic Hybrids Inc is recalling 171 MicroVue Bb Plus EIA kits because they produce concentration values approximately 50% higher than expected.

    Product
    MicroVue Bb Plus EIA is packaged as a kit which contains all reagent components to perform the test. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    11 states
  • LowFDA (Devices)·Z-0792-2013·2013-02-13

    Diagnostic Hybrids RhMK Culture Media Recalled for Fungal Contamination

    Diagnostic Hybrids is recalling RhMK culture media due to fungal contamination. The affected products are used to cultivate viruses from patient specimens.

    Product
    Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide