Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Brand
Aniara Diagnostica LLC
Lot Codes / Batch Numbers
F1701084, F1900611
Products Sold
F1701084, F1900611
Aniara Diagnostica LLC is recalling ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. due to Residual crystallization of the microplate and recurrent negative controls out of range.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Residual crystallization of the microplate and recurrent negative controls out of range.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
NH, NY, NC, OH
Page updated: Jan 10, 2026