Z-1928-2021Class I

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

Name: Z-1928-2021 Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Creator: Quidel Corporation
Published: 2021-04-27
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2021-04-27 / Terminated / root cause: design

FDA source

Quidel Corporation began a recall of Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent on 2021-04-27. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1928-2021
Classification: Class I
Status: Terminated
Initiated: 2021-04-27
Posted: 2021-06-26
Terminated: 2022-09-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Product code: QJR Reagents, 2019-Novel Coronavirus Nucleic Acid
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1928-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1928-2021	Class I	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-25

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)