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U.S. Department of Health and Human Services

Class 1 Device Recall Lyra SARSCoV2 Assay (M120)

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 Class 1 Device Recall Lyra SARSCoV2 Assay (M120)see related information
Date Initiated by FirmApril 27, 2021
Date PostedJune 26, 2021
Recall Status1 Terminated 3 on September 08, 2022
Recall NumberZ-1928-2021
Recall Event ID 87996
Product Classification Reagents, 2019-novel coronavirus nucleic acid - Product Code QJR
ProductLyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Code Information 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 
Recalling Firm/
Manufacturer		 Quidel Corporation
2005 E State St Ste 100
Athens OH 45701-2125
For Additional Information ContactRonald H. Lollar
740-818-3530
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn May 13, 2021, Quidel issued an Urgent Medical Device Correction notice to customers via email notifying them that Quidel has determined that there is a potential for 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 specified applications. YOU NEED TO TAKE THE FOLLOWING ACTIONS: 1. Immediately review the revised Lyra SARS CoV 2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/136820/download. 2. For clinical specimens generating Ct values d5, perform 1:10 and 1:100 dilutions using uninoculated transport media, extract, and test the diluted samples according to the Lyra SARS CoV 2 IFU. Refer to the Lyra SARS CoV 2 Assay IFU for full, detailed instructions. 3. It is recommended that any data which has been previously generated be re-evaluated and samples re-tested, as needed. 4. Complete the enclosed Field Corrective Action Fax Back form acknowledging receipt and understanding of the recommended actions. Return to Quidel Technical Support via fax at 858.203.9297 or via email to customernotifications@quidel.com.
Quantity in Commerce29,787 kits (96 results/kit)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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