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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 24

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  Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 24 see related information
Date Initiated by Firm October 27, 2011
Date Posted February 07, 2012
Recall Status1 Terminated 3 on February 12, 2016
Recall Number Z-0971-2012
Recall Event ID 60794
510(K)Number K042643  
Product Classification Calibrator, secondary - Product Code JIT
Product VITROS¿ Chemistry Products Calibrator Kit 24, Catalog No. 680 1708. Common/Usual Name: VITROS Calibrator Kit 24. For in vitro diagnostics use only. VITROS Chemistry Products Calibrator Kit 24 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 albumin in urine. Ortho-Clinical Diagnostics Inc.
Code Information Kit Lot 2430 (exp. 11/16/11), Kit Lot 2440 (exp. 01/08/12), Kit Lot 2450 (03/09/12), Kit Lot 2471 (exp. 7/14/12)
Recalling Firm/
Ortho-Clinical Diagnostics
100 Indigo Creek Drive
Rochester NY 14626
For Additional Information Contact Jennifer Paine
Manufacturer Reason
for Recall
Ortho Clinical Diagnostics received numerous complaints of lower than expected results for control fluids and patient samples upon initial calibration or following a recalibration using VITROS¿ Chemistry Products Calibrator Kit 24 and VITROS¿ Chemistry Products mALB Reagent.
FDA Determined
Cause 2
Nonconforming Material/Component
Action All consignees were sent "Important Product Correction Notification" communications (dated 10/27/11) beginning on 10/27/11 informing them of the issue, and instructing them to discontinue use of their remaining inventory of VITROS¿ Chemistry Products Calibrator Kit 24, VITROS¿ Chemistry Products mALB reagent, and VITROS¿ Chemistry Products mALB Performance Verifiers. For questions, please contact OCD's Customer Technical Services at 1-800-421-3311.
Quantity in Commerce 4436 units worldwide (domestic - 2201; foreign - 2235)
Distribution Worldwide Distribution - USA, including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, 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 = Ortho-Clinical Diagnostics, Inc.