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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products White Reference Slides

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  Class 2 Device Recall VITROS Chemistry Products White Reference Slides see related information
Date Initiated by Firm January 09, 2014
Date Posted March 19, 2014
Recall Status1 Terminated 3 on July 07, 2015
Recall Number Z-1226-2014
Recall Event ID 67282
510(K)Number K840880  K922072  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
Product VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number.
Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
Code Information Lot 9052-0045-6358, expiry date 01 Aug 2015
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information Contact Jennifer Paine
908-218-8776
Manufacturer Reason
for Recall		 An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658.
FDA Determined
Cause 2		 Error in labeling
Action Ortho Clinical Diagnostics sent an Urgent Distributor Product Correction Notification letter dated January 9, 2014, via FedEx overnight courier to all affected customers. The letter notified users of the issue and the correct 460 nm value. Foreign affitliates were notified on January 9, 2014 via e-mail. The letter advised users to inspect their current inventory of VITROS White Correction Slides to determine if Lot 9052-0045-6358 is present. If there is remaining inventory of VITROS White correction Slides, Lot 9052-0045-6358, the remaining inventory may be discarded or the user may continue to use the product with the updated 460nm value provided. If VITROS White Correction Slides, Lot 9052-0045-6358 have been previously used to perform the reflectometer correction factors adjustment , then this procedure should be repeated using the corrected 460 nm values or an alternate lot of VITROS White Correction Slides. Customers were instructed to complete and return the Confirmation of Receipt Form and identify all customers and any other branches who were shipped the affected lot from their facility and send a copy of the customer communication. Customers were also instructed to forward the information if they have distributed the affected product outside of their facility. Customers with questions were instructed to call Customer Technical Services. For questions regarding this recall call 908-218-8776.
Quantity in Commerce 64 units worldwide
Distribution Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to 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 = CIG and Original Applicant = EASTMAN KODAK COMPANY
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