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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 2

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 Class 2 Device Recall VITROS Chemistry Products Calibrator Kit 2see related information
Date Initiated by FirmOctober 17, 2013
Date PostedFebruary 25, 2014
Recall Status1 Terminated 3 on May 18, 2018
Recall NumberZ-1088-2014
Recall Event ID 66774
510(K)NumberK081411 K922072 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductVITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 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 CHOL, Cl-, ECO2, K+, Na+, and TRIG.
Code Information Product Code 1662659; Lots: 1) 212 and 2) 292; Expiry Dates: 1) 2014-08-31 and 2) 2014-02-28.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
Manufacturer Reason
for Recall		Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
FDA Determined
Cause 2		Under Investigation by firm
ActionOrtho Clinical Diagnostics sent an Urgent Product Correction Notification dated October 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Ortho Clinical Diagnostics recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample. Please forward a copy of the notification letter if the products were further distributed. Complete and return the attached Confirmation of Receipt form by October 25, 2013. Customers with questions please call Customer Technical Service at 1-800-421-3311.
Quantity in Commerce19,368 units total (10,328 for lot 212 and 9,040 for lot 292)
DistributionWorldwide Distribution - USA (nationwide) including Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, France, Italy and Spain.
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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