VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative mea...
FDA Recall #Z-1179-2017 — Class II — December 8, 2016
Product Description
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Reason for Recall
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Recalling Firm
Ortho-Clinical Diagnostics — Rochester, NY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated