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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators

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  Class 2 Device Recall VITROS Immunodiagnostic Products CA 199 Reagent Pack and CA 199 Calibrators see related information
Date Initiated by Firm July 16, 2014
Date Posted August 11, 2014
Recall Status1 Terminated 3 on March 06, 2017
Recall Number Z-2183-2014
Recall Event ID 68890
Product Classification System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
Product VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320

VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
Code Information Lot 1320, Product code: 6800035 and 6800040
Recalling Firm/
Manufacturer		 ORTHO-CLINICAL DIAGNOSTICS
FELINDRE MEADOWS
Bridgend United Kingdom
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 Customers may receive positively biased results when using VITROS¿ Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS¿ CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.
FDA Determined
Cause 2		 Other
Action Ortho Clinical Diagnostics sent an Urgent Product Correction Notification July 2014 to all affected customers. The Notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to Immediately discontinue using and discard Lots 1320 of VITROS CA 19-9 Calibrators and Reagent Packs. Review previously reported VITROS 25-OH Vitamin D Total results using Lot 1320. Review quality control results used to verify calibration events. Results lower than the target mean may indicate potentially biased assay results. Discuss any concerns regarding previously reported results with the Laboratory Medical Director or with the requesting physician. Complete and return the attached Confirmation of Receipt form. OCD will: credit their account for all VITROS¿ CA 19-9 Calibrators and Reagent Packs that were discarded or ship repalcment product uspon request. Customers were instructed to forward the information in this notification if they have distributed this product outside of their facility. Customers with questions were instructed to contact their Customer Technical Service representative or contact the Customer Technical Service representative at 1-800-421-3311.
Quantity in Commerce 475
Distribution Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
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.
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