When you or someone you know suffers a severe allergy reaction, the quick use of an epinephrine injector is likely needed. But one drugmaker says it’s recalling tens of thousands of those devices because they might not work correctly. 

Sanofi SA, a French drugmaker, announced Wednesday that it would recall all of the Auvi-Q injectors currently on the market – about 490,000 packs of the devices in the U.S – because they may not deliver the correct dose.

If a patient experiencing a serious allergic reaction – known as anaphylaxis – does not receive the intended dose, there could be significant health consequences, including death.

According to a recall notice from the Food & Drug Administration, there have been 26 reports of suspected device malfunctions in the U.S. and Canada.

In the reports, patients described symptoms of the underlying hypersensitivity reaction. No deaths have been linked to the issue.

Auvi-Q is packaged with two active devices and one trainer device in a corrugated box, and distributed throughout the U.S. at wholesalers, pharmacies, and hospitals.

Sanofi says all customers using Auvi-Q should immediately contact their healthcare providers for a prescription for an alternate epinephrine auto-injector.

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