Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ZYMUTEST HIA IgGAM 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 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.
Quantity: 281
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