ImmuAdd

IMMUCOR, INC. · Model 0002008 · UDI-DI 10888234000167

KSG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.

Recalls

Date	Firm	Reason
2019-10-14	Ortho Clinical Diagnostics Inc	Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.