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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products UPRO Slides

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  Class 2 Device Recall VITROS Chemistry Products UPRO Slides see related information
Date Initiated by Firm December 08, 2016
Create Date February 09, 2017
Recall Status1 Terminated 3 on June 22, 2018
Recall Number Z-1179-2017
Recall Event ID 75936
510(K)Number K964960  
Product Classification Lowry (colorimetric), total protein - Product Code JGP
Product VITROS Chemistry Products UPRO Slides, UPN 10758750000593,


Product Usage:
Quantitative measurement of total protein concentration in urine.
Code Information Product Code REF 680 0120 Lot: GENs 14-18  Expiry Date range 01-JAN-2017 through 01-MAY-2018
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Ortho Care Technical Solutions Center
585-453-4224
Manufacturer Reason
for Recall		 There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
FDA Determined
Cause 2		 Device Design
Action On December 8, 2016, Ortho Clinical Diagnostics distributed Product Correction Notification letters to their customers via FedEx, ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to check their stock for affected product and to immediately discontinue and discard all remaining inventory. Ortho will credit your account for any discarded VITROS UPRO Slides, VITROS Chemistry Products Calibrator Kit 10 and/or VITROS Chemistry Products UPRO Performance Verifier I & II. Please complete the Confirmation of Receipt and return by December 22, 2016. Customers with questions, please contact Ortho CareTM Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 37,571 packs/90 slides totalling 3,381,390 slides
Distribution Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
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 = JGP and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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