medical Class II Updated 2024-12-04

Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CRP Slides- In vitro diagnostic qu

Recalled Product

VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/GTIN 10758750000296 Coating 1221, expiration date 10/01/2024 Coating 1222, expiration date 01/01/2025
View official government recall

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