Blood Grouping Reagents - ORTHO Sera, ALBAclone
The FDA has provided approval information for ORTHO Sera Anti-D (DVI) blood grouping reagents, specifically for the in vitro detection of Rh D (DVI) positive red blood cells via direct agglutination.
This affects manufacturers of blood grouping reagents, clinical laboratory professionals, and facilities performing RhD testing using ORTHO Sera and ALBAclone products.
The source indicates a critical usage restriction: this reagent is not intended for patient or neonatal testing because it detects partial RhD (DVI). Misapplication in these populations could lead to incorrect RhD status determination. Regulatory and QA teams must ensure that such diagnostic tools are strictly sequestered for their approved indications to maintain testing accuracy and patient safety in blood banking environments.
Regulatory and clinical teams should verify that Laboratory Information Systems (LIS) and standard operating procedures (SOPs) explicitly prohibit the use of this specific reagent for patient and neonatal testing to prevent inappropriate RhD detection results. Ensure labeling and instructions for use (IFU) are strictly followed regarding testing population restrictions.
Product approval information is indicated for:<br> •ORTHO Sera Anti-D (DVI) is for the in vitro detection of human Rh D (DVI) positive red blood cells by the direct agglutination test. Patients and neonates should not be tested with this reagent since it detects partial RhD (DVI).<br> •ORTHO Sera Anti-D (IA
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