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Acceava®

Model 92001 · Alere San Diego, Inc. · DI 10815845020031

GTY — Antigens, All Groups, Streptococcus Spp. · Class I · 21 CFR 866.3740

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 (2)

InitiatedRecall #ClassStatusReasonLink basis
2024-08-20Z-3185-2024Class IIOpen, ClassifiedDue to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.code info di
2022-05-25Z-1598-2022Class IIOpen, ClassifiedFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.code info di

Adverse-event reports — MAUDE (2)

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: 2

142842562019-06: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 5/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 11/device2022-03: 0 reports for this device; peer average 8/device2022-06: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 5/device2023-02: 0 reports for this device; peer average 13/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 4/device2023-05: 2 reports for this device; peer average 2.5/device2023-06: 0 reports for this device; peer average 7/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 9/device2024-03: 0 reports for this device; peer average 4/device2024-04: 0 reports for this device; peer average 3/device2024-05: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 4/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 3/device2024-11: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 5/device2025-05: 0 reports for this device; peer average 6/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 4/device2025-08: 0 reports for this device; peer average 3/device2025-09: 0 reports for this device; peer average 28/device2025-10: 0 reports for this device; peer average 2.5/device2025-11: 0 reports for this device; peer average 10/device2025-12: 0 reports for this device; peer average 4/device2026-01: 0 reports for this device; peer average 7/device2026-02: 0 reports for this device; peer average 56/device2026-03: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 5/device2026-06: 0 reports for this device; peer average 4/device060401020304060708091112010306081012020304050608091011120102030405060710110305060708091011120102030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0601
2020-0401
2021-0102
2021-0201
2021-0301
2021-0402
2021-0603
2021-0703
2021-0802
2021-0901
2021-1105
2021-1201
2022-01011
2022-0308
2022-0603
2022-0801
2022-1001
2022-1205
2023-02013
2023-0302
2023-0404
2023-0522.5
2023-0607
2023-0802
2023-0901
2023-1001
2023-1102
2023-1204
2024-0101
2024-0209
2024-0304
2024-0403
2024-0503
2024-0604
2024-0701
2024-1003
2024-1106
2025-0305
2025-0506
2025-0601
2025-0704
2025-0803
2025-09028
2025-1002.5
2025-11010
2025-1204
2026-0107
2026-02056
2026-0301
2026-0505
2026-0604
This device (reports/month)Average device in GTY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Alere San Diego, Inc.

  • Warning Letter 2012-10-10 Alere San Diego, Inc.
  • NAI 2025-12-10 Alere San Diego Inc. · 0 citations
  • VAI 2019-01-11 Alere San Diego, Inc. · 2 citations
  • VAI 2015-06-05 Alere San Diego, Inc. · 0 citations
  • NAI 2014-10-29 Alere San Diego Inc. · 0 citations
  • VAI 2014-06-27 Alere San Diego, Inc. · 10 citations
  • OAI 2012-06-27 Alere San Diego, Inc. · 7 citations
  • NAI 2011-08-01 Alere San Diego Inc. · 0 citations