VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration
FDA device recall Z-0535-2025 · posted 2024-11-25 · Open, Classified
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Reason for recall
- 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.
- Action taken
- 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 250/350/5,1 FS/4600/5600/XT 3400/XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Root Cause Our investigation is ongoing; however, additional testing has been implemented in our release process to mitigate this issue prior to the release of future coatings of VITROS CRP Slides
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- DCK
- Quantity affected
- 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
- Date initiated
- 2024-10-11
- Date posted
- 2024-11-25
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7 (K152433) | Ortho Clinical Diagnostics | 2015-09-24 |
| EKTACHEM CLINICAL CHEMISTRY SLIDE C-REACTIVE PROTEIN (CRP) (K953197) | Johnson & Johnson Clinical Diagnostics, Inc. | 1995-07-31 |