Recall Z-2477-2021 ยท QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
Quidel Corporation
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
| Date | Aug 13, 2021 |
| Status | Terminated |
| Reason | Revised Instructions for Use: Potential for specimens from 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 the Thermo Fisher QuantStudio 7 Pro, the Applied Biosystems 7500 Fast Dx, the Applied Biosystems 7500, the Bio-Rad CFX96 Touch", the Roche LightCycler LC 480 II/ cobas z 480, or the Qiagen Rotor-Gene MDx. |
| Root cause | Under Investigation by firm |
| Action | Quidel issued Urgent Medical Device Correction letter on August 13, 2021. Letter states reason for recall, health risk and action to take: For samples generating a Ct value between 0 (Undetermined) and 5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the instructions above. Interpret the results according to Table 5 above. Note that if review of the original amplification curve from the neat sample is not suggestive of a positive result, processing of the diluted specimens may be deferred. If the |
| Quantity | 81,910 kits |
| Distribution | Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.