FDAFDA · Food and drugs·Recall number Z-0535-2025
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Published December 4, 2024 · Recall initiated: October 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- 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, Spain, Sweden, The Netherlands, United Kingdom.
- Lot
- UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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