FDA recall Z-0410-2019

R & D Systems, Inc. · Class III · device

Product

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

IA and CO

Key facts

Status: Terminated
Initiation date: 2018-09-11
Report date: 2018-11-14
Termination date: 2020-09-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0410-2019