Home / Recalls / Aniara Diagnostica LLC / Z-1188-2019

Z-1188-2019 Class III Terminated

Recalled by Aniara Diagnostica LLC — West Chester, OH

Recall Details

Product Type
Devices
Report Date
April 24, 2019
Initiation Date
March 19, 2019
Termination Date
July 12, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14 kits

Product Description

BIOPHEN UFH Control C2, REF 223901

Reason for Recall

The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.

Distribution Pattern

Distributed to accounts in MI and PA.

Code Information

Lot F1700315P7

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-2347-2019 Class II — ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnost (July 19, 2019)
  • Z-1190-2019 Class III — BIOPHEN LMWH Control C4, REF 224201 (March 19, 2019)
  • Z-1189-2019 Class III — BIOPHEN UFH Control C1, REF 224101 (March 19, 2019)