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U.S. Department of Health and Human Services

Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 9

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  Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 9 see related information
Date Initiated by Firm September 28, 2015
Date Posted November 02, 2015
Recall Status1 Terminated 3 on May 22, 2018
Recall Number Z-0202-2016
Recall Event ID 72289
510(K)Number K941142  K081543  
Product Classification Calibrator, secondary - Product Code JIT
Product VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.
Code Information Lot 0954, exp. date 31-May-2016
Recalling Firm/
Ortho-Clinical Diagnostics
1000 Lee Road
Rochester NY 14606
For Additional Information Contact Ms. Jennifer Paine
Manufacturer Reason
for Recall
The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.
FDA Determined
Cause 2
Under Investigation by firm
Action Customer letter (Ref. CL2015-191) was sent on 9/28/2015 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, discard the remaining inventory of the affected lot and recalibrate VITROS DGXN and PHYT Slides using Cal Kit 9 with an alternative lot of calibrator kit 9 upon availability. Distributor letter (Ref. DL2015-191) was sent on 9/28/2015 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. The foreign affiliates were notified via e-mail on 9/28/2015.
Quantity in Commerce Domestic: 2443 kits; Foreign: 1548 kits
Distribution Nationwide, Puerto Rico and foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of 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 = JIT and Original Applicant = EASTMAN KODAK COMPANY
510(K)s with Product Code = JIT and Original Applicant = Ortho-Clinical Diagnostics, Inc.