Recall Z-0535-2025 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Ortho-Clinical Diagnostics, Inc.
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
| Date | Nov 25, 2024 (initiated Oct 11, 2024) |
| Status | Open, Classified |
| Reason | May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90 mg/L range) while the samples having higher than 90 mg/L. User no way to know if the sample has to be diluted to measure again. |
| Root cause | Under Investigation by firm |
| Action | QuidelOrtho issued Urgent Product Correction Notification letter on 10.21.24. Letter states reason for recall, health risk and action to take: " Discontinue using, render unusable, and discard all remaining inventory of lots manufactured from the affected coating(s) of VITROS Chemistry Products CRP Slides. " Complete and return the enclosed Confirmation of Receipt form. Upon receipt of your completed Confirmation of Receipt form, QuidelOrtho will credit or replace your discarded inventory. " Save this notification with your User Documentation or post this notification by each VITROS 250/350/5, |
| Quantity | 7717 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AZ, FL, ID, IL, KS, MN, MT, NY, PA, UT and the countries of Australia, Belgium, Bermuda, Brazil, Canada L3R 0B8, Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, |
| FDA record | Open on fda.gov |