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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS (R) Chemistry Products FS Calibrator 1

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  Class 2 Device Recall VITROS (R) Chemistry Products FS Calibrator 1 see related information
Date Initiated by Firm May 12, 2014
Date Posted June 16, 2014
Recall Status1 Terminated 3 on March 23, 2017
Recall Number Z-1805-2014
Recall Event ID 68286
510(K)Number K041799  K063164  
Product Classification Calibrators, drug mixture - Product Code DKB
Product VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only --- VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate the VITROS 5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Code Information Lots 91131 (exp. 07-Mar-2015) and 91241 (exp. 28-Feb-2016) 
Recalling Firm/
Ortho-Clinical Diagnostics
1000 Lee Road
Rochester NY 14606
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.
FDA Determined
Cause 2
Process change control
Action Customer Product Correction Letters (CL2014-143, dated 5/12/14) were sent on 5/12/2014 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot(s), and inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Distributor letter (DL2014-143) was also sent on 5/12/2014 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. Foreign affiliates were pre-notified via e-mail on 5/08/2014 that the communication of this issue and required actions is imminent and were sent the finalized recall communication on 5/12/2014.
Quantity in Commerce Domestic - 464 units; Foreign - 361 units
Distribution Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
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 = DKB and Original Applicant = Ortho-Clinical Diagnostics, Inc.