ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
- Company
- Aniara Diagnostica Llc
- Recall Initiated
- July 19, 2019
- Terminated
- June 11, 2021
- Recall Number
- Z-2347-2019
- Quantity
- 46
- Firm Location
- West Chester, OH
Reason for Recall
Residual crystallization of the microplate and recurrent negative controls out of range.
Distribution
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Lot / Code Info
F1701571
Root Cause
Under Investigation by firm
Action Taken
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.
More recalls by Aniara Diagnostica Llc
BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C activity on human ci...
Mar 6, 2023
BIOPHEN UFH Control Plasma
Jun 28, 2022
BIOPHEN LMWH Control C4, REF 224201
Mar 19, 2019
BIOPHEN UFH Control C2, REF 223901
Mar 19, 2019