CLASS I Device recall · Reported 7 Jul 2021 · FDA Enforcement Report
Lyra Sars-CoV-2 Assay (M120) in vitro diagnostic test reagent recalled
Quidel is recalling Lyra Sars-CoV-2 Assay (M120) in vitro diagnostic test reagent, distributed nationwide in the US. The recall was initiated on 27 Apr 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1928-2021
- FDA event ID
- 87996
- Recalling firm
- Quidel, Athens, OH
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 27 Apr 2021
- FDA classified
- 25 Jun 2021
- Reported
- 7 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Apr 2021 | Recall initiated by company | |
| 25 Jun 2021 | Classified by FDA | +59 days |
| 7 Jul 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent
Where it was distributed
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.
Nationwide AlabamaCaliforniaConnecticutDistrict of ColumbiaFloridaIdahoIndianaMassachusettsMichiganMissouriNew MexicoNew YorkOhioSouth CarolinaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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