Summary
The FDA issued a Class I for Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent by Quidel Corporation. 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 cert.
Details
Source
Device Recall
External ID
Z-1928-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Lot/Code Info: Lot Number: 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
Quantity Affected: 29,787 kits (96 results/kit)
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-27
Company
Athens, OH
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quidel Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quidel Corporation have FDA actions?
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1928-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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