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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Hyphen BioMed
- Reason for Recall:
- Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2
Distribution:
Distributed in: OH, MD, NC, NY, NH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1744-2018
Related Recalls
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
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.