Skip to content
Recall Observatory FDA recall evidence

Device 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.

Z-1063-2018

November 09, 2011

Class II

Product summary

Firm
Hyphen BioMed
Event
Event 79269
Status
Terminated
Classification
Class II
Quantity
30
Official record key
device-enforcement:Z-1063-2018

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: 03663537046810. Lot Number: F1700416.

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.