CLASS II Device recall · Reported 22 Sep 2021 · FDA Enforcement Report
Lyra Direct Sars-CoV-2 Assay Emergency Use Authorization recalled
Quidel is recalling Lyra Direct Sars-CoV-2 Assay Emergency Use Authorization, distributed nationwide in the US. The recall was initiated on 13 Aug 2021 and the FDA has classified it as Class II.
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-2477-2021
- FDA event ID
- 88498
- Recalling firm
- Quidel, Athens, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2021
- FDA classified
- 15 Sep 2021
- Reported
- 22 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Aug 2021 | Recall initiated by company | |
| 15 Sep 2021 | Classified by FDA | +33 days |
| 22 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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 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
Where it was distributed
Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
All lots
Where was it sold?
Worldwide distribution - US Nationwide distribution including Puerto Rico and the countries of Canada, Panama, Virgin Islands, Germany, Honduras.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Quidel
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | QuickVue Dipstick Strep A Test, 50T recalled by Quidel | Quidel | Other | Nationwide |
| Device | CLASS II | QuickVue: Dipstick Strep A Test: 50T recalled by Quidel | Quidel | Other | Nationwide |
| Device | CLASS II | InflammaDry MMP-9 Test recalled by Quidel | Quidel | Hidden Drug Ingredients | 38 states |
| Device | CLASS II | InflammaDry MMP-9 Test recalled by Quidel | Quidel | Hidden Drug Ingredients | 38 states |
| Device | CLASS II | The Sofia 2 Flu + SARS Antigen FIA employs recalled by Quidel | Quidel | Device Malfunction | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,661| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | McKesson Consult hCG Urine Cassette recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Systems/units containing affected recalled | Beckman Coulter Mishima K.K | Device Malfunction | Nationwide |
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | CLASS II | Vitek 2 Ast-N461 Test Kit, Gram Negative Susceptibility recalled | Biomerieux | Other | MO |
| Device | CLASS II | DASH Rapid PCR Instrument recalled by Nuclein | Nuclein | Device Malfunction | Nationwide |