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BinaxNOW COVID-19 Antigen Self Test
Model 195-160 · Alere Scarborough, Inc. · DI 00811877011408
QYT — Over-The-Counter Covid-19 Antigen Test · Class II · 21 CFR 866.3984
UDILibrary device dossier · generated 2026-09-15 · 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 (1834)
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.
Malfunction: 1722 · Injury: 111 · Death: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2021-05
3
3
2021-06
4
4
2021-07
29
29
2021-08
48
48
2021-09
65
65
2021-10
19
19
2021-11
24
24
2021-12
44
44
2022-01
59
30
2022-02
43
15.33
2022-03
21
11.5
2022-04
36
19
2022-05
40
20.5
2022-06
56
15.25
2022-07
39
14
2022-08
48
13
2022-09
63
22
2022-10
44
44
2022-11
114
39.33
2022-12
58
30
2023-01
107
54.5
2023-02
76
26
2023-03
67
34.5
2023-04
45
45
2023-05
69
35
2023-06
18
18
2023-07
17
17
2023-08
37
20
2023-09
39
14.67
2023-10
75
75
2023-11
58
58
2023-12
51
17.67
2024-01
93
32
2024-02
61
31.5
2024-03
25
14
2024-04
6
6
2024-05
7
4
2024-06
2
1.5
2024-07
15
6
2024-08
20
7.75
2024-09
7
4
2024-10
6
5
2024-11
6
2.75
2024-12
9
5.5
2025-01
10
6.75
2025-02
2
1.5
2025-03
8
4.5
2025-04
5
3
2025-05
1
1
2025-06
4
3
2025-07
1
1
2025-08
2
2
2025-09
2
1.5
2025-10
5
5
2025-11
4
5.5
2025-12
4
4
2026-01
2
2
2026-02
4
4
2026-03
3
3
2026-04
2
2
2026-05
2
2
This device (reports/month)Average device in QYT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Alere Scarborough, Inc.