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ViroKey™ SX Virus Total Nucleic Acid Kit
VELA OPERATIONS SINGAPORE PTE. LTD. · Model 300677 · UDI-DI 08885013958188
10
510(k) clearances
295
Adverse events (1 deaths)
31
Recalls
99
Facilities
Description
The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-03 | Qiagen Sciences LLC | Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Pr |
| 2024-03-04 | Qiagen Sciences LLC | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample b |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2023-02-21 | Entopsis , Inc. | Presence of misleading label statements on the product label. |
| 2022-11-02 | Qvella Corporation | Device exceeds the limitations of a Class I 510(k)-exempt device so the user manual, instructions for use, and promotional materials are being corrected to remove all references to |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.