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U.S. Department of Health and Human Services

Class 3 Device Recall R&D systems, a biotechne brand Human Total 25OH Vitamin D IVD ELISA Kit

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 Class 3 Device Recall R&D systems, a biotechne brand Human Total 25OH Vitamin D IVD ELISA Kitsee related information
Date Initiated by FirmSeptember 11, 2018
Create DateNovember 09, 2018
Recall Status1 Terminated 3 on September 01, 2020
Recall NumberZ-0410-2019
Recall Event ID 81121
510(K)NumberK123364 
Product Classification System, test, vitamin d - Product Code MRG
ProductR&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971
Code Information Manufacturing Lot # 182801
FEI Number 2182501
Recalling Firm/
Manufacturer		 R & D Systems, Inc.
614 McKinley Pl NE
Minneapolis MN 55413-2610
For Additional Information ContactRachel Somsen
612-851-4846
Manufacturer 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.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThe 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 Commerce8 kits
DistributionIA and CO
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = MRG
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