Recall Z-1928-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Quidel Corporation
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
| Date | Jun 26, 2021 (initiated Apr 27, 2021) |
| Status | Terminated |
| Reason | In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when certain amplification and detection platforms (thermocyclers) are used. These specimens would be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5. There have been no formal complaints of False Negative results with Ct values <5 from Lyra SARS-CoV-2 Assay users. |
| Root cause | Device Design |
| Action | On May 13, 2021, Quidel issued an Urgent Medical Device Correction notice to customers via email notifying them that Quidel has determined that there is a potential for patients with high SARS CoV 2 viral loads to be falsely interpreted as negative if target amplification occurs prior to a cycle threshold (Ct) value of 5 when using specified applications. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately review the revised Lyra SARS CoV 2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/136820/download. 2. For clinical specimens |
| Quantity | 29,787 kits (96 results/kit) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, CT, DC, FL, ID, IN, MA, MI, MO, NM, NY, OH, SC, TN, TX, WA and the countries of Canada, Saudi Arabia, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.