Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Sofia

Model 20377 · QUIDEL CORPORATION · DI 30014613339229

QMN — Covid-19 Multi-Analyte Antigen Device

UDILibrary device dossier · generated 2026-09-16 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (1)

InitiatedRecall #ClassStatusReasonLink basis
2024-01-03Z-1086-2024Class IIOpen, ClassifiedOne lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expiration date of May 31, 2025, however the correct expiration date for the pouches is September 12, 2024. The kits are labeled with an expiration date of April 30, 2025, however, the correct expiration date for the kits is September 12, 2024. The issue was discovered on November 28, 2023 by a supply chain employee who determined that the kits had expiration dates beyond the FDA authorized shelf life.code info di

Adverse-event reports — MAUDE (5754)

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: 5750 · Injury: 4

5491098164721962022-03: 187 reports for this device; peer average 187/device2022-04: 1078 reports for this device; peer average 1078/device2022-05: 2196 reports for this device; peer average 2196/device2022-06: 619 reports for this device; peer average 619/device2022-07: 75 reports for this device; peer average 75/device2022-08: 78 reports for this device; peer average 78/device2022-09: 50 reports for this device; peer average 50/device2022-10: 40 reports for this device; peer average 40/device2022-11: 22 reports for this device; peer average 22/device2022-12: 46 reports for this device; peer average 46/device2023-01: 49 reports for this device; peer average 49/device2023-02: 123 reports for this device; peer average 123/device2023-03: 285 reports for this device; peer average 285/device2023-04: 52 reports for this device; peer average 52/device2023-05: 8 reports for this device; peer average 8/device2023-06: 26 reports for this device; peer average 26/device2023-07: 8 reports for this device; peer average 8/device2023-08: 79 reports for this device; peer average 79/device2023-09: 63 reports for this device; peer average 63/device2023-10: 41 reports for this device; peer average 41/device2023-11: 57 reports for this device; peer average 57/device2023-12: 78 reports for this device; peer average 78/device2024-01: 57 reports for this device; peer average 57/device2024-02: 12 reports for this device; peer average 12/device2024-03: 27 reports for this device; peer average 27/device2024-04: 14 reports for this device; peer average 14/device2024-05: 5 reports for this device; peer average 5/device2024-06: 7 reports for this device; peer average 4/device2024-07: 5 reports for this device; peer average 5/device2024-08: 41 reports for this device; peer average 41/device2024-09: 8 reports for this device; peer average 8/device2024-10: 46 reports for this device; peer average 46/device2024-11: 33 reports for this device; peer average 17/device2024-12: 9 reports for this device; peer average 9/device2025-01: 30 reports for this device; peer average 30/device2025-02: 18 reports for this device; peer average 18/device2025-03: 15 reports for this device; peer average 15/device2025-04: 5 reports for this device; peer average 5/device2025-05: 12 reports for this device; peer average 12/device2025-06: 7 reports for this device; peer average 7/device2025-08: 6 reports for this device; peer average 6/device2025-09: 1 reports for this device; peer average 1/device2025-10: 1 reports for this device; peer average 1/device2025-11: 39 reports for this device; peer average 39/device2025-12: 13 reports for this device; peer average 13/device2026-01: 15 reports for this device; peer average 15/device2026-02: 18 reports for this device; peer average 18/device2026-03: 18 reports for this device; peer average 18/device2026-04: 22 reports for this device; peer average 22/device2026-06: 10 reports for this device; peer average 10/device0304050607080910111201020304050607080910111201020304050607080910111201020304050608091011120102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-03187187
2022-0410781078
2022-0521962196
2022-06619619
2022-077575
2022-087878
2022-095050
2022-104040
2022-112222
2022-124646
2023-014949
2023-02123123
2023-03285285
2023-045252
2023-0588
2023-062626
2023-0788
2023-087979
2023-096363
2023-104141
2023-115757
2023-127878
2024-015757
2024-021212
2024-032727
2024-041414
2024-0555
2024-0674
2024-0755
2024-084141
2024-0988
2024-104646
2024-113317
2024-1299
2025-013030
2025-021818
2025-031515
2025-0455
2025-051212
2025-0677
2025-0866
2025-0911
2025-1011
2025-113939
2025-121313
2026-011515
2026-021818
2026-031818
2026-042222
2026-061010
This device (reports/month)Average device in QMN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — QUIDEL CORPORATION

  • NAI 2021-08-03 Quidel Corporation · 0 citations
  • VAI 2018-01-29 Quidel Corporation · 5 citations
  • VAI 2017-04-10 Quidel Corporation · 0 citations
  • NAI 2014-01-13 Quidel Corporation · 0 citations
  • NAI 2013-05-21 Quidel Corporation · 0 citations
  • VAI 2013-01-17 Quidel Corporation · 1 citations
  • NAI 2011-03-16 Quidel Corporation · 0 citations