R & D Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0410-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: September 11, 2018

Date Posted: November 14, 2018

Recall Number: Z-0410-2019

Event ID: 81121

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.

Status: Terminated

Product Quantity: 8 kits

Code Information:

Manufacturing Lot # 182801

Distribution Pattern:

IA and CO

Voluntary or Mandated:

Voluntary: Firm initiated