Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZYMUTEST HIA MonoStrip IgG Recalled by Hyphen BioMed Due to Incorrect package insert indicating use of the kits...
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 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.
Quantity: 12
Why Was This Recalled?
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Where Was This Sold?
This product was distributed to 5 states: MD, NH, NY, NC, OH
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