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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS

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 Class 2 Device Recall VITROSsee related information
Date Initiated by FirmFebruary 02, 2012
Date PostedMarch 22, 2012
Recall Status1 Terminated 3
Recall NumberZ-1277-2012
Recall Event ID 61175
510(K)NumberK001679 K922072 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductVITROS 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 2		Software design
ActionOrtho 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
DistributionWorldwide Distribution - USA (nationwide)
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JIX
510(K)s with Product Code = JIX
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