Aniara Diagnostica LLC: Medical Device Recall in 2019 - (Recall #: Z-2346-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: July 19, 2019

Date Posted: August 28, 2019

Recall Number: Z-2346-2019

Event ID: 83487

Reason for Recall:

Residual crystallization of the microplate and recurrent negative controls out of range.

Status: Terminated

Product Quantity: 51

Code Information:

F1701084, F1900611

Distribution Pattern:

Distribution to US states of NC, NH, NY, and OH, and Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated