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Recall Observatory FDA recall evidence

Device 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.

Z-1062-2018

November 09, 2011

Class II

Product summary

Firm
Hyphen BioMed
Event
Event 79269
Status
Terminated
Classification
Class II
Quantity
94
Official record key
device-enforcement:Z-1062-2018

Official wording

Reason: A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.

Code information: UDI: 03663537018770 Lot Number: F1700415

Distribution pattern: Worldwide Distribution - US Distribution and to the countries of : Austria and France.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.