Recall Z-1179-2017
Ortho-Clinical Diagnostics · initiated December 8, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Codes / lots: Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018
Reason for recall
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1179-2017
- Initiated
- December 8, 2016
- Terminated
- June 22, 2018
- Product code
- JGP – Lowry (Colorimetric), Total Protein
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY