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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 2 see related information
Date Initiated by Firm December 16, 2019
Create Date February 13, 2020
Recall Status1 Terminated 3 on November 12, 2020
Recall Number Z-1226-2020
Recall Event ID 84654
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
Product VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG
Product Code: 1662659
Code Information Lot # /Exp. Date: Lot 277 11-Dec-2019; Lot 288 31-May-2020; Lot 298 12-Nov-2020; Lot 219 15-Jul-2021.  UDI: 10758750009503
Recalling Firm/
Manufacturer		 Ortho Clinical Diagnostics Inc
1001 US Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-1300
Manufacturer Reason
for Recall		 Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Products Calibrator Kit 2
FDA Determined
Cause 2		 Under Investigation by firm
Action Ortho Clinical Diagnostics (Ortho) 16 December 2019, customer letter (Ref. CL2019-343) was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail.Letter states reason for recall , health risk and provided with required actions depending upon whether VITROS Calibrator Kit 32 was available for use. VITROS Calibrator Kit 32 is available for use in the U.S. therefore the required actions in order to process urine samples on VITROS Na+ Slides are to:calibrate. o discontinue using the calibration for urine sodium (only) obtained using an affected VITROS Calibrator Kit 2 lot until either VITROS Na+ Slide GEN 27 is available and/or GEN 26 performance is updated in mid-late January 2020 (refer to Resolution section). Ortho will expedite 1 sales unit of VITROS Calibrator Kit 32, if needed. Request via Confirmation of Receipt form. o Use an alternate urine sodium method until calibration with VITROS Calibrator Kit 32 is complete. o If no alternate urine sodium method is available for use, consult with your medical director to determine if the urine sodium calibration obtained using an affected VITROS Calibrator Kit 2 lot is acceptable for continued use until: ¿ Calibration with VITROS Calibrator Kit 32 is complete or ¿ VITROS Na+ Slides GEN 26 performance is updated (refer to Resolution section of the communication). VITROS Calibrator Kit 2 is acceptable to use after this occurs or ¿ VITROS Na+ Slides GEN 27 or higher is available. VITROS Calibrator Kit 2 will be acceptable to use. Questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 39709 units (12734 US and 26975 OUS)
Distribution Nationwide Foreign: Australia Brazil Canada L3R 4G5 Chile China Colombia India Japan Mexico Singapore United Kingdom France Germany Italy Spain Portugal Poland Russia Denmark Norway Sweden Belgium Netherlands
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.
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