Recall Z-2347-2019 ยท LCO Platelet Factor 4 Radioimmunoassay
Aniara Diagnostica LLC
ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
| Date | Jul 19, 2019 |
| Status | Terminated |
| Reason | Residual crystallization of the microplate and recurrent negative controls out of range. |
| Root cause | Under Investigation by firm |
| Action | The firm notified customers of the recall via Urgent Medical Device Correction emails dated July 26, 2019. Customers were informed of the recall and asked to destroy the affected kits in stock and indicate the quantity in the Awareness Acknowledgement Form, which was to be signed and returned to the local distributor. If you have any questions regarding this recall, please contact Aniara at (513) 360-6377, or CMurphy@aniara.com. |
| Quantity | 46 |
| Distribution | Distribution to US states of NC, NH, NY, and OH, and 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 |