Recall Z-1179-2017 ยท JGP Lowry (Colorimetric), Total Protein
Ortho-Clinical Diagnostics
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
| Date | Dec 8, 2016 |
| Status | Terminated |
| Reason | There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides. |
| Root cause | 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. Customer |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964960 | VITROS CHEMISTRY PRODUCTS UPRO SLIDES Johnson & Johnson Clinical Diagnostics, Inc., Feb 18, 1997 |