Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

Date: 07/07/2021

Product type:  Medical Device

Recalled Product

  • Lyra SARS-CoV-2 Assay (M120)
  • Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, 032820B, 040320, 040720, 040920, 041020, 174992, 175429, 175501, 175502, 175503, 176001, 176002, 176366, 176367, 176368, 178984, 178985, 180331, 180332, 180673, 180674, 180675, 182594, 184273, 185535, 185822, 186470, 186472, 187062, 187173, 187822, 189232, 189942, 190786, 193074, 193977
  • Manufacturing Dates: March 17, 2020 to March 12, 2021
  • Distribution Dates: March 17, 2020 to May 27, 2021
  • Devices Recalled in the U.S.: 18385 (each kit contains 96 reactions)
  • Date Initiated by Firm: April 26, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/quidel-recalls-lyra-sars-cov-2-assay-m120-due-risk-false-negative-results