Home / Recalls / Aniara Diagnostica LLC / Z-2347-2019

Z-2347-2019 Class II Terminated

Recalled by Aniara Diagnostica LLC — West Chester, OH

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
46

Product Description

ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, 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

F1701571

Other recalls by Aniara Diagnostica LLC

  • Z-1227-2023 Class II — BIOPHEN Protein C 5 kit is for in vitro quantitative determination of Protein C (February 1, 2023)
  • Z-1743-2022 Class III — BIOPHEN UFH Control Plasma (June 28, 2022)
  • Z-2346-2019 Class II — ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic (July 19, 2019)
  • Z-1190-2019 Class III — BIOPHEN LMWH Control C4, REF 224201 (March 19, 2019)
  • Z-1188-2019 Class III — BIOPHEN UFH Control C2, REF 223901 (March 19, 2019)
  • Z-1189-2019 Class III — BIOPHEN UFH Control C1, REF 224101 (March 19, 2019)