Home › Device types › QJR
Reagents, 2019-Novel Coronavirus Nucleic Acid
FDA product code QJR · Class N · Unknown
50
Registered devices
20,142
Adverse events
40
Recalls
0
510(k) clearances
Devices with this code
Alinity m — ABBOTT MOLECULAR INC.Biomeme Franklin three9 Real-Time PCR Thermocycler — Biomeme, Inc.Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit — Gold Standard Diagnostics CorporationGold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit — Gold Standard Diagnostics CorporationAccula Programming Cassette — MESA BIOTECH, INC.NeuMoDx SARS-CoV-2 Test Strip — Neumodx Molecular, Inc.Lyra — DIAGNOSTIC HYBRIDS, INC.Smart DetectTM SARS-CoV-2 rRT-PCR Kit — INBIOS INTERNATIONAL, INCAlinity m — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.Biomeme SARS-CoV-2 Go-Plates — Biomeme, Inc.EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AGBiomeme DNA/RNA Preservation Buffer (100/pk) — Biomeme, Inc.RealTime — ABBOTT MOLECULAR INC.EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AGBioFire® Respiratory Panel 2.1 EUA — BIOFIRE DIAGNOSTICS, LLCAccula Dock — MESA BIOTECH, INC.EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AGBiomeme Franklin three9 Real-Time PCR Thermocycler — Biomeme, Inc.Biomeme SARS-CoV-2 Go-Strips Kit — Biomeme, Inc.BioFire® Respiratory Panel 2.1-EZ EUA, 30 Tests — BIOFIRE DIAGNOSTICS, LLCBiomeme Franklin three9 Real-Time PCR Thermocycler — Biomeme, Inc.EURORealTime SARS-CoV-2 — EUROIMMUN Medizinische Labordiagnostika AGGold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit — Gold Standard Diagnostics Corporation
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-28 | Abbott Molecular, Inc. | There were reports of an increase in reactive negative controls and false positive results. |
| 2025-04-28 | Abbott Molecular, Inc. | There were reports of an increase in reactive negative controls and false positive results. |
| 2024-05-07 | Becton Dickinson & Co. | Assays may produce false negative results due to decreased activity of the enzyme utilized in manufacturing. |
| 2023-05-15 | NeuMoDx Molecular Inc | Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 1 |
| 2023-05-09 | Qiagen GmbH | If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that l |
| 2023-01-30 | DiaSorin Molecular LLC | Direct amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and error code |
| 2022-12-15 | Meridian Bioscience Inc | Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen con |
| 2022-11-22 | Abbott Molecular, Inc. | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. |
| 2022-11-22 | Abbott Molecular, Inc. | Reports of an increase in reactive negative controls and false positive results with certain lots of Alinity M Resp-4-Plex AMP kits. |
| 2022-09-14 | Luminex Corporation | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. |
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