Quidel Recalls Lyra SARS-CoV-2 Assay (M120)

Serious illness or death may result from the use of these devices. The FDA has identified this as a Class I recall, the most serious type of

If your email program has trouble displaying this email, view as a webpage. Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results Quidel is recalling its Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus. False negative results may lead to delayed diagnosis or treatment of SARS-CoV-2 which may cause patient harm including serious illness and death. Read More The FDA has identified this as a Class I Recall, the most serious type of recall. Use of these devices may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2 that may cause patient harm, serious illness, and death. Questions? If you have questions about this recall, contact the Division of Industry and Consumer Education (DICE).

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