FDA recall Z-1928-2021

Product

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

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.

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.

Key facts

Status

Terminated

Initiation date

2021-04-27

Report date

2021-07-07

Termination date

2022-09-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Athens, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1928-2021