The Recall Desk

Manufacturer

Hyphen BioMed

5 recalls in our database name Hyphen BioMed as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2018-05-16

Of the 5 recalls from Hyphen BioMed 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.

1–5 of 5

  • ModerateFDA (Devices)·Z-1743-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA MonoStria Assay Due to Labeling Error

    Hyphen BioMed is recalling ZYMUTEST HIA MonoStria kits because the package insert incorrectly lists serum and other fluids as valid sample types.

    Product
    ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1744-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA IgGAM Assay Kits Due to Incorrect Package Insert

    Hyphen BioMed is recalling 281 units of the ZYMUTEST HIA IgGAM assay because the package insert incorrectly states the kits can be used with serum and other fluids, when they should only be used with plasma.

    Product
    ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1742-2018·2018-05-16

    Hyphen BioMed Recalls ZYMUTEST HIA MonoStrip IgG Assay Kits

    Hyphen BioMed is recalling 12 ZYMUTEST HIA MonoStrip IgG kits because the package insert incorrectly lists serum and other fluids as valid sample types.

    Product
    ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1062-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Risk

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.

    Product
    ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1063-2018·2018-03-21

    Hyphen BioMed Recalls ZYMUTEST HIA Assays Due to False Positive Results

    Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.

    Product
    ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.
    Category
    Medical Device
    Distribution
    0 states