Recall Z-0410-2019— R & D Systems, Inc.

Name: FDA recall Z-0410-2019
Creator: U.S. Food and Drug Administration
Published: 2018-09-11

Class III · Terminated

Class III FDA medical device recall by R & D Systems, Inc., initiated 2018-09-11, terminated 2020-09-01. It names one FDA 510(k) clearance: K123364. Product: R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971. Reason: 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..

Recalling firm: R & D Systems, Inc.
Classification: Class III
Status: Terminated
Initiated: 2018-09-11
Terminated: 2020-09-01
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K123364 — 25OH VITAMIN D TOTAL ELISA TESTDiasource Immunoassays, S.A.·cleared 2013-07-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.