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Genedrive(R)96 SARS-CoV2-kit
GENEDRIVE DIAGNOSTICS LTD · Model 1 · UDI-DI 05060654860127
QLT
Prescription
0
510(k) clearances
1,693
Adverse events
11
Recalls
9
Facilities
Description
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-05 | Luminex Molecular Diagnostics Inc | Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified pred |
| 2023-05-19 | Qiagen GmbH | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-05-19 | Qiagen GmbH | Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated |
| 2023-04-28 | Qiagen Sciences LLC | Faulty cartridges in the lot could result in false test results. |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to addition |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to addition |
| 2022-12-21 | Roche Molecular Systems, Inc. | The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to addition |
| 2022-05-13 | NeuMoDx Molecular Inc | There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowi |
| 2021-11-08 | Qiagen Sciences LLC | The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negat |
| 2021-08-04 | Roche Molecular Systems, Inc. | Customers have reported an increased number of false positive SARS-CoV-2 results. |
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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.