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1017960 HealthFirst Mail-In Spore Testing Service, 12 Test
Model HF-Y12 · MESA LABORATORIES, INC. · DI M985HFY120
FRC — Indicator, Biological Sterilization Process · Class II · 21 CFR 880.2800
UDILibrary device dossier · generated 2026-09-11 · 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)
2019-01
0
2
2019-02
0
1
2019-04
0
3
2019-05
0
3
2019-06
0
1
2019-07
0
1
2019-08
0
1
2019-09
0
1
2019-10
0
3
2019-11
0
4
2019-12
0
3
2020-01
0
2
2020-02
0
1
2020-03
0
3
2020-04
0
5
2020-05
0
2
2020-10
0
1
2021-01
0
1
2021-02
0
1
2021-04
0
2
2021-07
0
1
2021-11
0
1
2022-02
0
3
2022-05
0
2
2022-06
0
1
2022-07
0
1
2022-08
0
2
2022-09
0
1
2022-10
0
3
2023-01
0
3
2023-02
0
3
2023-03
0
3
2023-08
0
2
2023-12
0
3.67
2024-01
0
4.75
2024-02
0
1
2024-06
0
1
2024-08
0
1
2024-09
0
2
2024-11
0
3
2025-05
0
1
2025-08
0
2
2025-10
0
1
2025-11
0
1
2025-12
0
2
This device (reports/month)Average device in FRC (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MESA LABORATORIES, INC.