Recall Z-1743-2018— Hyphen BioMed
Class II · Terminated
Class II FDA medical device recall by Hyphen BioMed, initiated 2018-02-05, terminated 2018-08-16. It names one FDA 510(k) clearance: K071255. Product: 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 Number: RK041D; UDI: 03663537046810. Reason: Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma..
- Recalling firm
- Hyphen BioMed
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-05
- Terminated
- 2018-08-16
- Firm location
- Neuville Sur Oise, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 Number: RK041D; UDI: 03663537046810
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.