Class 2 Device Recall VITROS

• Date Initiated by Firm: February 02, 2012
• Date Posted: March 22, 2012
• Recall Status: Terminated
• Recall Number: Z-1277-2012
• Recall Event ID: 61175
• 510(K)Number: K922072 K001679
• Product Classification: Calibrator, multi-analyte mixture - Product Code JIX
• Product: VITROS Chemistry Products --- ALT Slides --- [REF] 165 5281 --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA. The recalled device is the calibration disk contained within the VITROS Calibrator Kit 3. The is can be identified with the label "VITROS Chemist y Systems --- Universal Calibration Diskette --- [REF] 871 6607 --- Ortho-Clinical Diagnostics"; ; For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 3 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 AcP, ALT, ALKP, AMYL, AST, CK, GGT, LDH, and LIPA.
• Code Information: Calibration Diskette (Product Code 8716607) and the Assay Data Diskette (Product Code 6801876), Data Release Version (DRV) 5653 through 5666 used in conjuction with of VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
• Recalling Firm/ Manufacturer: Ortho-Clinical Diagnostics; 100 Indigo Creek Dr; Rochester NY 14626-5101
• For Additional Information Contact: 800-421-3311
• Manufacturer Reason for Recall: Ortho Clinical Diagnostics received complaints of lower than expected results (< 6 U/L) for samples that were known to be outside of the measuring (reportable) range (> 1000 U/L) when using Calibration Diskette/Assay Data Diskette Data Release Version (DRV) 5653 through 5666 and VITROS¿ Chemistry Products ALT Slides, Generation (GEN) 26 (Product Code 1655281).
• FDA Determined Cause: Software design
• Action: Ortho Clinical Diagnostic sent a Important Product Correction letter dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers to: Install Calibration Diskette/Assay Data Diskette DRV 5667 on your VITROS System. Following a successful recalibration, you may resume using VITROS¿ ALT Slides, GEN 26 remaining in your inventory. To please complete and return the Confirmation of Receipt form upon receipt of this notification. Please return this form no later than February 17, 2012. Post this notification by each VITROS¿ System in your facility that utilizes the VITROS¿ ALT Slides, or with the VITROS¿ user documentation. Forward this notification if you have distributed this product outside of your facility. We apologize for the inconvenience this may have caused your facility. If you have any additional questions, please contact Customer Technical Services at 1-800-421-3311.
• Quantity in Commerce: 4306
• Distribution: Worldwide Distribution - USA (nationwide)
• 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 = JIX and Original Applicant = EASTMAN KODAK COMPANY; 510(K)s with Product Code = JIX and Original Applicant = Ortho-Clinical Diagnostics, Inc.