Neuville Sur Oise, N/A, France
Hyphen BioMed recalls
2 recalls recorded since 2018, most recently on 5 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 5 February 2018
- Terminated
- 16 August 2018
- Reason
- Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
- Distribution
- OH, MD, NC, NY, NH, Canada, Sweden
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1743-2018, Z-1744-2018, Z-1742-2018
- ZYMUTEST HIA MonoStria 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. p IgGAM; REF Numb
- 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
- ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is inte
Terminated Class II Medical devices
- Recall started
- 9 November 2011
- Terminated
- 21 June 2018
- Reason
- 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
- Worldwide Distribution - US Distribution and to the countries of : Austria and France.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1062-2018, Z-1063-2018
- 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.
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.