Z-0410-2019Class III

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

Name: Z-0410-2019 R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Creator: R & D Systems, Inc.
Published: 2018-09-11
License: https://open.fda.gov/license/

R & D Systems, Inc. / initiated 2018-09-11 / Terminated / root cause: labeling and UDI

FDA source

R & D Systems, Inc. began a recall of R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 on 2018-09-11. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0410-2019
Classification: Class III
Status: Terminated
Initiated: 2018-09-11
Posted: 2018-11-09
Terminated: 2020-09-01
Recalling firm: R & D Systems, Inc.
Product: R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Product code: MRG System, Test, Vitamin D
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.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: The firm contacted the consignees (end users) by telephone on 09/11/2018 to alert them of the issue. The firm followed with an email on 09/21/2018 restating the issue and offering to replace any unused kits.
Quantity in commerce: 8 kits
Distribution: IA and CO
Product codes and lots: Manufacturing Lot # 182801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0410-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0410-2019	Class III	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-08

Product code MRG

K123364Class II25Oh Vitamin D Total Elisa TestDiasource Immunoassays, S.A. / cleared 2013-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)