Z-2477-2021Class II

Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a...

Name: Z-2477-2021 Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a...
Creator: Quidel Corporation
Published: 2021-08-13
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-08-13 / Terminated / root cause: labeling and UDI

FDA source

Quidel Corporation began a recall of 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... on 2021-08-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2477-2021
Classification: Class II
Status: Terminated
Initiated: 2021-08-13
Posted: 2021-09-15
Terminated: 2023-11-02
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Quidel issued Urgent Medical Device Correction letter on August 13, 2021. Letter states reason for recall, health risk and action to take: For samples generating a Ct value between 0 (Undetermined) and 5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the instructions above. Interpret the results according to Table 5 above. Note that if review of the original amplification curve from the neat sample is not suggestive of a positive result, processing of the diluted specimens may be deferred. If the diluted samples generate Ct values between 0 (Undetermined) and 5, please contact a Quidel Representative at (800) 874-1517 (toll-free in the U.S.) or (858) 552-1100 (outside of U.S.), Monday through Friday, between 8:00 a.m. and 5:00 p.m., Eastern for additional instructions. 1. Immediately review the revised Lyra Direct SARS-CoV-2 Assay Instructions for Use (IFU) for updated Result Interpretation guidance: https://www.fda.gov/media/138178/download 2. For clinical specimens generating Ct values <5, perform 1:10 and 1:100 dilutions using uninoculated Process Buffer. Process (including the heat step) and test the diluted samples according to the Lyra Direct SARS-CoV-2 IFU. Refer to the Lyra Direct 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 Filed 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 [email protected]. Representatives are available to assist you in this process and answer any questions you may have about this recall. Please contact Quidel Technical Support at [email protected] or by calling 800.874.1517, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST.
Quantity in commerce: 81,910 kits
Distribution: Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2477-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2477-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-15

Product code QJR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)