ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
FDA Recall Z-2347-2019 · Posted None
Recalling FirmAniara Diagnostica LLC
Recall StatusTerminated
Product CodeLCO
Date Initiated2019-07-19
Date Terminated2021-06-11
Product Quantity46
Reason for Recall
Residual crystallization of the microplate and recurrent negative controls out of range.
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 [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.