V tem sklopu so prikazana varnostna obvestila za medicinske pripomočke, ki jih prejme JAZMP s strani proizvajalcev ali predstavnikov proizvajalcev in se tičejo ukrepov oz. medicinskih pripomočkov, vezanih na tematiko COVID – 19.
| Datum | Številka zadeve | Proizvajalec | Medicinski pripomoček |
|---|---|---|---|
| 08.06.2022 | P301-122/2022 | nal von minden GmbH, DE | NADAL® COVID-19 Ag+Influenza A/B plus Test |
| 29.04.2022 | P301-92/2022 | Seegene Inc., KR | Allplex SARS-CoV-2 Variants II Assay |
| 28.02.2022 | P301-28/2022 | NeuMoDx Molecular, a QIAGEN Company, ZDA | NeuMoDx Cartridge |
| 14.02.2022 | 301-283/2021 | Abbott Molecular, Inc., ZDA | Alinity m system Posodobljeno varnostno obvestilo |
| 07.12.2021 | 301-283/2021 | Abbott Molecular, Inc., ZDA | Alinity m System Obvestilo 1, Obvestilo 2 |
| 07.12.2021 | 301-282/2021 | Abbott Molecular, Inc., ZDA | Alinity m System Obvestilo 1, Obvestilo 2 |
| 07.12.2021 | 301-281/2021 | Abbott Molecular, Inc., ZDA | Alinity m System Obvestilo 1, Obvestilo 2 |
| 08.11.2021 | 301-258/2021 | Life Technologies Corporation, a part of Thermo Fisher Scientific, ZDA | TaqPath™ COVID-19 CE-IVD RT-PCR Kit |
| 3.9.2021 | 301-214/2021 | Abbott Molecular, Inc., ZDA | Alinity m SARS-CoV-2 Amplification Reagent Kit Kit (List Numbers 09N78-090 and 09N78-091) Alinity m Resp-4-Plex Amplification Reagent Kit ( List Number 09N79-090) |
| 25.08.2021 | 301-203/2021 | QIAGEN GmbH, DE | QIAstat-Dx® Respiratory SARS-CoV-2 Panel |
| 15.07.2021 | 301-126/2021 | Beckman Coulter, Inc., ZDA | SARS-CoV-2 IgG II Reagent and Calibrator Posodobljeno varnostno obvestilo |
| 21.5.2021 | 301-126/2021 | Beckman Coulter, Inc., ZDA | SARS-CoV-2 IgG II Reagent and Calibrator |
| 11.05.2021 | 301-119/2021 | NeuMoDx Molecular, a QIAGEN Company, ZDA | NeuMoDx Cartridge |
| 10.05.2021 | 301-118/2021 | Bosch Healthcare Solutions GmbH, DE | Vivalytic SARS-CoV-2 and SARS-CoV-2 Pooling |
| 22.03.2021 | 301-71/2021 | Roche Molecular Systems, ZDA | cobas® SARS-CoV-2 & Influenza A/B Test |
| 03.03.2021 | 301-50/2021 | Life Technologies Corporation, a part of Thermo Fisher Scientific, ZDA | TaqPath™ COVID-19 CE-IVD RT-PCR kit |
| 18.02.2021 | 301-39/2021 | Ortho Clinical Diagnostics Inc, GB | VITROS SARS-CoV-2 Antigen Reagent |
| 29.01.2021 | 301-14/2021 | Shenzhen Ultra-Diagnostics Biotec. Co., Ltd., CN | Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2) Antigen Test Kit |
| 11.01.2021 | 301-279/2020 | VivaChek Biotech (Hangzhou) Co., Ltd., CN | VivaDiag SARS-CoV-2 Ag Rapid Test |
| 29.12.2020 | 301-280/2020 | QIAGEN GmbH, DE | QIAstat-Dx Respiratory SARS-CoV-2 Panel |
| 17.07.2020 | 301-161/2020 | Ortho Clinical Diagnostics Inc, ZDA | VITROS Anti-SARS-CoV-2 Total Reagent Pack |
| 04.05.2020 | 301-102/2020 | VivaChek Laboratories, Inc., ZDA | VivaDiag COVID-19 IgM/IgG Rapid Test |
