The Recall Desk

FDA (Devices) recall action 79642

Diagnostic Hybrids, Inc. recalled 3 products on 2018-05-02

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-05-02
Critical
0
Units
198

Why these products were recalled

A component of the kit was found to contain bacterial contamination.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    11 states
  • ModerateFDA (Devices)··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
    Distribution
    11 states
  • ModerateFDA (Devices)··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
    Distribution
    11 states