VITROS CRP Slides (Ortho-Clinical) – Result Bias Issue (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Brand
Ortho-Clinical Diagnostics, Inc.
Lot Codes / Batch Numbers
UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025
Products Sold
UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026