|
Device |
reagents, 2019-novel coronavirus nucleic acid |
Definition |
Nucleic acid-based in vitro diagnostic devices for the detection of 2019-novel coronavirus (2019-nCoV) and/or diagnosis of 2019-nCoV infection in human clinical specimens. |
Product Code | QJR |
Device Class |
Not Classified
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott Molecular, Inc. |
II |
May-12-2025 |
2 |
Abbott Molecular, Inc. |
II |
Dec-20-2022 |
3 |
Abbott Molecular, Inc. |
II |
Sep-06-2022 |
4 |
Abbott Molecular, Inc. |
I |
Oct-14-2021 |
5 |
Becton Dickinson & Co. |
II |
Jun-05-2024 |
6 |
Becton Dickinson & Co. |
II |
Apr-13-2021 |
7 |
Becton Dickinson & Co. |
II |
Feb-05-2021 |
8 |
Becton Dickinson & Co. |
II |
Aug-04-2020 |
9 |
Biomeme, Inc. |
II |
Jan-04-2022 |
10 |
Biomeme, Inc. |
III |
Feb-01-2021 |
11 |
Biomeme, Inc. |
II |
Dec-01-2020 |
12 |
DNA Genotek Inc. |
II |
Apr-21-2022 |
13 |
DiaSorin Molecular LLC |
II |
Mar-03-2023 |
14 |
DiaSorin Molecular LLC |
II |
Oct-21-2021 |
15 |
GS Biomark LLC |
II |
Nov-29-2022 |
16 |
Life Technologies Corporation |
II |
Sep-17-2020 |
17 |
Luminex Corporation |
II |
Oct-26-2022 |
18 |
Luminex Corporation |
II |
Aug-17-2022 |
19 |
MESA BIOTECH, INC |
I |
May-06-2022 |
20 |
Meridian Bioscience Inc |
II |
Jan-20-2023 |
21 |
Meridian Bioscience Inc |
II |
May-07-2021 |
22 |
NeuMoDx Molecular Inc |
III |
Jul-05-2023 |
23 |
NeuMoDx Molecular Inc |
II |
Apr-22-2022 |
24 |
NeuMoDx Molecular Inc |
II |
Mar-08-2022 |
25 |
NeuMoDx Molecular Inc |
II |
Jun-29-2021 |
26 |
OPTI Medical Systems, Inc |
II |
Aug-17-2021 |
27 |
Qiagen GmbH |
II |
Jul-21-2023 |
28 |
Quidel Corporation |
II |
Sep-15-2021 |
29 |
Quidel Corporation |
I |
Jun-26-2021 |
30 |
Roche Molecular Systems, Inc. |
II |
Apr-13-2021 |
31 |
VISBY MEDICAL INC |
II |
Jan-12-2021 |
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