Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay Recalled by Hyphen BioMed Due to A voluntary recall is initiated for ZYMUTEST HIA...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Hyphen BioMed directly.
Affected Products
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.
Quantity: 30
Why Was This Recalled?
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.
Where Was This Sold?
Worldwide Distribution - US Distribution and to the countries of : Austria and France.
About Hyphen BioMed
Hyphen BioMed has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report