Hyphen BioMed: Medical Device Recall in 2018 - (Recall #: Z-1744-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: February 5, 2018

Date Posted: May 16, 2018

Recall Number: Z-1744-2018

Event ID: 79797

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.

Status: Terminated

Product Quantity: 281

Code Information:

Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2

Distribution Pattern:

OH, MD, NC, NY, NH, Canada, Sweden

Voluntary or Mandated:

Voluntary: Firm initiated