Z-2346-2019 Class II Terminated
FDA device recall Z-2346-2019 was initiated by Aniara Diagnostica LLC on July 19, 2019 and is designated Class II. Reason for recall: Residual crystallization of the microplate and recurrent negative controls out of range. The recall status is terminated (terminated June 11, 2021). Affected quantity: 51.
Recall Details
- Product Type
- Devices
- Report Date
- August 28, 2019
- Initiation Date
- July 19, 2019
- Termination Date
- June 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51
Product Description
ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
Reason for Recall
Residual crystallization of the microplate and recurrent negative controls out of range.
Distribution Pattern
Distribution to US states of NC, NH, NY, and OH, and Sweden.
Code Information
F1701084, F1900611