Anti-Human Globulin Anti-IgG (Rabbit) (Green) IH-Card AHG Anti-IgG
Received Jul 3, 2026 · Event occurred May 28, 2026
Report 9610824-2026-00018 · MDR key 25701449
Device
Generic name
Ih-card Ahg Anti-igg (rabbit); 288 Cards
Manufacturer
Bio-rad Medical Diagnostics GmbhCatalog number
813422100
Lot number
9511030
Product problems
- False Negative Result
Patient
Unknown
- Hemolysis
- Hypersensitivity/Allergic reaction
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
CUSTOMER REPORTED THAT A PATIENT EXPERIENCED A TRANSFUSION REACTION. THE ANTIBODY SCREEN IN GEL USING IH-CARD AHG ANTI-IGG (PN 813422100, LOT 9511030, EXPIRY 7/12/2026) FOR THE PRE-TRANSFUSION SAMPLE WAS NEGATIVE. THE ANTIBODY SCREEN IN GEL USING IH-CARD AHG ANTI-IGG (PN 813422100, LOT 9511030, EXPIRY 7/12/2026) FOR THE POST-TRANSFUSION SAMPLE WAS NEGATIVE. CUSTOMER REPORTED SHE RAN THE PRE-TRANSFUSION AND POST-TRANSFUSION SAMPLES ON THE IMMUCOR ECHO AND IDENTIFIED AN ANTI-JKA.
Additional Manufacturer Narrative
INITLAL REPORT.