Home / Recalls / Hyphen BioMed / Z-1062-2018

Z-1062-2018 Class II Terminated

Recalled by Hyphen BioMed — Neuville Sur Oise

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
November 9, 2011
Termination Date
June 21, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94

Product Description

ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.

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.

Distribution Pattern

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

Code Information

UDI: 03663537018770 Lot Number: F1700415

Other recalls by Hyphen BioMed

  • Z-1744-2018 Class II — ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screen (February 5, 2018)
  • Z-1743-2018 Class II — ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detec (February 5, 2018)
  • Z-1742-2018 Class II — ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitativ (February 5, 2018)
  • Z-1063-2018 Class II — ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assa (November 9, 2011)