Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time
Summary
The FDA issued a Class II for Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyr by Quidel Corporation. 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 a.
Details
Source
Device Recall
External ID
Z-2477-2021
Action Date
2021-09-22
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: All lots
Quantity Affected: 81,910 kits
Reason for Recall
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.
Distribution
Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Athens, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 142 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2477-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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