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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 Slidessee related information
Date Initiated by FirmDecember 08, 2016
Create DateFebruary 09, 2017
Recall Status1 Terminated 3 on June 22, 2018
Recall NumberZ-1179-2017
Recall Event ID 75936
510(K)NumberK964960 
Product Classification Lowry (colorimetric), total protein - Product Code JGP
ProductVITROS 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
FEI Number 1000305840
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information ContactOrtho 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
ActionOn 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 Commerce37,571 packs/90 slides totalling 3,381,390 slides
DistributionWorldwide 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 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 = JGP
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