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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products dLDL Reagent

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  Class 2 Device Recall VITROS Chemistry Products dLDL Reagent see related information
Date Initiated by Firm October 08, 2018
Create Date November 17, 2018
Recall Status1 Terminated 3 on October 13, 2022
Recall Number Z-0476-2019
Recall Event ID 81376
510(K)Number k041720  
Product Classification System, test, low density, lipoprotein - Product Code MRR
Product VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC)
Product Code: 6801728
UDI (10758750006793)
Code Information Lot Numbers:   1517-26-6396 (expires 6-Nov-2018)  1517-26-6582 (expires 2-Feb-2019)  1517-26-6639 (expires 2-Feb-2019)  1517-27-6808 (expires 7-May-2019)   
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		 VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho Clinical Diagnostics issue the customer notification on October 8, 2018, provides information regarding the potential for biased results when using VITROS dLDL Reagent, Generations (GENs) 26 and 27. Actions to take: For GEN 26: Discontinue using GEN 26 and switch to an alternate GEN of product as soon as possible. Please specify full or partial sales units remaining and indicate credit or replacement on your Confirmation of Receipt form. " For GEN 27: Install ADD DRV 6003 on your VITROS System upon receipt. Following a successful recalibration, resume using VITROS dLDL Reagent, GEN 27 remaining in your inventory. " Complete the Confirmation of Receipt form and return by October 22, 2018. Questions contact our Ortho Care" Technical Solutions Center at 1-800-421-3311
Quantity in Commerce 5850 units
Distribution Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MRR and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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