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BBL™ CultureSwab™
Model 220134 · COPAN ITALIA SPA · DI 38053326002008
JSM — Culture Media, Non-Propagating Transport · Class I · 21 CFR 866.2390
UDILibrary device dossier · generated 2026-09-12 · 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
1
2019-02
0
1
2019-03
0
1
2019-04
0
1
2019-05
0
1.5
2019-06
0
3
2019-07
0
12.5
2019-08
0
1
2019-09
0
2
2019-10
0
1
2019-11
0
1
2019-12
0
2
2020-04
0
2
2020-05
0
1
2020-06
0
2
2020-07
0
2
2020-08
0
1.6
2020-09
0
1
2020-10
0
1
2020-11
0
3
2020-12
0
1
2021-01
0
1
2021-02
0
1
2021-03
0
2
2021-04
0
1
2021-05
0
1
2021-06
0
1
2021-07
0
1
2021-08
0
1.33
2021-09
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
2.33
2022-02
0
1
2022-03
0
1
2022-04
0
1
2022-06
0
2
2022-07
0
1
2022-09
0
2
2022-12
0
1.5
2023-02
0
1
2023-04
0
1
2023-05
0
2
2023-06
0
3
2023-07
0
3
2023-08
0
1.5
2023-09
0
1
2023-10
0
1
2023-11
0
1.5
2024-01
0
1
2024-03
0
1
2024-05
0
1
2024-06
0
1
2024-07
0
1
2024-08
0
1
2024-09
0
1.5
2024-10
0
1
2024-11
0
1
2025-01
0
2
2025-02
0
2.33
2025-03
0
3
2025-04
0
1
2025-05
0
2.5
2025-06
0
4
2025-07
0
1
2025-08
0
1.67
2025-09
0
1.5
2025-11
0
1
2025-12
0
6
2026-01
0
1
2026-04
0
3
2026-05
0
1
This device (reports/month)Average device in JSM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K946283 — cited as predicate by K142366
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — COPAN ITALIA SPA
Warning Letter 2012-05-14 Copan Italia
NAI 2022-07-14 COPAN INDUSTRIES, INC · 0 citations
NAI 2014-12-10 Copan Diagnostics Inc · 0 citations