FDA Medical devices recall ·
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively… recall
- Recall number
- Z-0535-2025
- Date
- (initiated October 11, 2024)
- Company / brand
- Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr, Rochester, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7717 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025
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, Spain, Sweden, The Netherlands, United Kingdom.
States: Arizona Florida Idaho Illinois Kansas Minnesota Montana New York Pennsylvania Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0535-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.