Hyphen BioMed: Medical Device Recall in 2018 - (Recall #: Z-1063-2018)

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 MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.

Product Classification:

Class II

Date Initiated: November 9, 2011

Date Posted: March 21, 2018

Recall Number: Z-1063-2018

Event ID: 79269

Reason for Recall:

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.

Status: Terminated

Product Quantity: 30

Code Information:

UDI: 03663537046810. Lot Number: F1700416.

Distribution Pattern:

Worldwide Distribution - US Distribution and to the countries of : Austria and France.

Voluntary or Mandated:

Voluntary: Firm initiated