Lyra SARS-CoV-2 Assay — Class I medical device recall Z-1928-2021
Terminated recall by Quidel Corporation, reported 2021-07-07, distributed nationwide. In rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct valu
| Recall number | Z-1928-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, Athens, OH, United States |
| Recall initiated | 2021-04-27 |
| Classified | 2021-06-25 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2022-09-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, SA |
| Reason classes | potency |
| Lot numbers | 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 and 3 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1928-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.