Recall Z-1928-2021— Quidel Corporation
Class I · Terminated
Class I FDA medical device recall by Quidel Corporation, initiated 2021-04-27, terminated 2022-09-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent. 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..
- Recalling firm
- Quidel Corporation
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-04-27
- Terminated
- 2022-09-08
- Firm location
- Athens, OH, United States
Product description
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.