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CorDx
Model CO291-2 · CORETESTS, INC. · DI 00850042559079
QKP — Coronavirus Antigen Detection Test System.
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2020-11
0
4
2020-12
0
10
2021-01
0
10.5
2021-02
0
6
2021-03
0
7
2021-04
0
97
2021-05
0
2.33
2021-06
0
2
2021-07
0
5
2021-08
0
6.25
2021-09
0
13.6
2021-10
0
14.67
2021-11
0
14.25
2021-12
0
40.86
2022-01
0
160.6
2022-02
0
262.88
2022-03
0
247.75
2022-04
0
236.6
2022-05
0
153
2022-06
0
266.25
2022-07
0
74.5
2022-08
0
174.67
2022-09
0
271.33
2022-10
0
220
2022-11
0
102
2022-12
0
183.5
2023-01
0
93.2
2023-02
0
405
2023-03
0
185.67
2023-04
0
98.33
2023-05
0
239
2023-06
0
29
2023-07
0
54
2023-08
0
22.25
2023-09
0
23
2023-10
0
7.75
2023-11
0
15
2023-12
0
6.67
2024-01
0
11.8
2024-02
0
5.75
2024-03
0
8.67
2024-04
0
4.67
2024-05
0
3
2024-06
0
4
2024-07
0
3.67
2024-08
0
10.5
2024-09
0
17
2024-10
0
9.8
2024-11
0
8.2
2024-12
0
2.33
2025-01
0
18.33
2025-02
0
23
2025-03
0
10
2025-05
0
17
2025-06
0
1
2025-07
0
1
2025-08
0
28
2025-09
0
11
2025-12
0
2
2026-04
0
1
2026-05
0
4
This device (reports/month)Average device in QKP (reports/device/month)