Home / Recalls / R & D Systems, Inc. / Z-0410-2019

Z-0410-2019 Class III Terminated

Recalled by R & D Systems, Inc. — Minneapolis, MN

Recall Details

Product Type
Devices
Report Date
November 14, 2018
Initiation Date
September 11, 2018
Termination Date
September 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8 kits

Product Description

R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971

Reason for Recall

The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.

Distribution Pattern

IA and CO

Code Information

Manufacturing Lot # 182801

Other recalls by R & D Systems, Inc.

  • Z-0999-2023 Class III — R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF (November 7, 2022)
  • Z-1390-2022 Class III — Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative contr (June 14, 2022)
  • Z-1255-2021 Class II — Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immuno (January 20, 2021)
  • Z-0691-2019 Class III — Quantikine¿ IVD¿ ELISA, Human sTfR Immunoassay kit. Product Usage: The Quant (November 1, 2018)
  • Z-2887-2016 Class II — R&D Systems, Quantikine¿ IVD¿sTfR Immunoassay Kit, for the quantitative determin (August 24, 2016)