The FDA's new mandated warning, announced Friday, comes after a recall in December of some skin tests used for testing food allergies.
At the time, the FDA said it had received"increased" reports of false negatives from some lots of an extract manufactured by ALK-Abello that is used to diagnose peanut allergies.
Anaphylaxis is a severe allergic reaction that can involve a sudden drop in blood pressure and difficulty breathing. It can be treated with a shot of epinephrine, but may be life-threatening without swift medical intervention. Some of the liquid extracts used to test for allergic reactions, like for cat hair or dust mites, are
to meet certain agreed-upon benchmarks for potency. However, the FDA says the drops used for testing food allergies like peanuts are not.An FDA spokesperson did not clarify how many reports it has received of life-threatening allergic reactions resulting from false negative food allergy tests.tallies 90 cases of false negative results, 17 reports of serious cases and no deaths.
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