Reported Jul 7, 2021 · Terminated
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Quidel Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quidel Corporation · 2005 E State St Ste 100 · Athens, OH · 45701-2125
Is this the product you have?
- Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
- Lot codes and dates
- Lot Number
031620A031620B031620C032320032420032720032820A032820B040320040720040920041020174992175429175501175502175503176001176002176366176367176368178984178985180331180332180673180674180675182594184273185535185822186470186472187062187173187822189232189942190786193074193977
- Lot Number
- Amount recalled
- 29,787 kits (96 results/kit)
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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