Recall Z-1742-2018— Hyphen BioMed

Name: FDA recall Z-1742-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-05

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 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 intended for in vitro diagnostic use.. 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 record

K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed·cleared 2007-09-07

K-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 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 intended for in vitro diagnostic use.

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.