Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent

FDA device recall Z-1928-2021 · posted 2021-06-26 · Terminated

Recall details

Recalling firm

Quidel Corporation

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.

Action taken

On 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.

Root cause

Device Design

Status

Terminated

Product code

QJR

Quantity affected

29,787 kits (96 results/kit)

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.

Date initiated

2021-04-27

Date posted

2021-06-26

Date terminated

2022-09-08

Location

Athens, OH