Recall Z-1743-2018 ยท LCO Platelet Factor 4 Radioimmunoassay
Hyphen BioMed
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
| 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 | 60 |
| 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 |