Home / Recalls / Aniara Diagnostica LLC / Z-2171-2026

Z-2171-2026 Class II Ongoing

Recalled by Aniara Diagnostica LLC — West Chester, OH

Recall Details

Product Type
Devices
Report Date
May 20, 2026
Initiation Date
April 1, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
359 units

Product Description

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Reason for Recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Distribution Pattern

US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI

Code Information

UDI-DI: 03663537018763; Lot Number: FD1265

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-2347-2019 Class II — ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnost (July 19, 2019)
  • 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)