VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
FDA Recall Z-1179-2017 · Posted None
Advertisement
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJGP
Date Initiated2016-12-08
Date Terminated2018-06-22
Product Quantity37,571 packs/90 slides totalling 3,381,390 slides
Reason for Recall
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement