FDA determined that the risk of anaphylaxis following false negative food allergen skin test results is applicable to all allergenic extracts for the diagnosis of food allergies. Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in Prescribing Information.

http://www.fda.gov/safety/medical-product-safety-information/all-allergenic-extracts-diagnosis-food-allergy-fda-safety-communication-fda-requires-warning-about