Recall Z-1742-2018 ยท LCO Platelet Factor 4 Radioimmunoassay
Hyphen BioMed
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.
| Date | Feb 5, 2018 |
| Status | Terminated |
| Reason | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| Root cause | Packaging process control |
| Action | On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at Sandra@aniara.com or by phone at (866)783-3797 ext. 110. |
| Quantity | 12 |
| Distribution | OH, MD, NC, NY, NH, Canada, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed, Sep 7, 2007 |