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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 29

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  Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 29 see related information
Date Initiated by Firm May 24, 2016
Create Date July 01, 2016
Recall Status1 Terminated 3 on June 08, 2018
Recall Number Z-2119-2016
Recall Event ID 74363
510(K)Number K052867  
Product Classification Ferrozine (colorimetric) iron binding capacity - Product Code JMO
Product VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
Code Information Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
1000 Lee Road
Rochester NY 14606
For Additional Information Contact Ms. Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 24, 2016, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to discontinue using the affected product until Assay Data Diskette (ADD) Data Realease Version (DRV) 5884 or above was installed on their VITROS System. Foreign affiliates were informed of the issue via e-mail on 5/24/2016 and instructed to notify their consignees of the issue and required actions. Customers with questions were advised to contact Ortho's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in Commerce US: 1517; Foreign: 842
Distribution Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, 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 = JMO and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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