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Alinity

Model 08P5820 · ABBOTT LABORATORIES · DI 00380740135331

KLT — Enzyme Immunoassay, Carbamazepine · Class II · 21 CFR 862.3645

UDILibrary device dossier · generated 2026-09-14 · 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.

23562019-01: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 6/device2023-11: 0 reports for this device; peer average 6/device2024-03: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 3/device0108091012040204061103020512
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0801
2019-0901
2019-1001
2019-1201
2020-0401
2021-0202
2022-0401
2022-0606
2023-1106
2024-0302
2025-0202
2025-0501.33
2025-1203
This device (reports/month)Average device in KLT (reports/device/month)

Regulatory clearances

  • K123518 SESE 2013-06-05 (k number procode)

Manufacturer compliance record — ABBOTT LABORATORIES

  • Warning Letter 2026-01-23 Abbott Diabetes Care, Inc.
  • Warning Letter 2022-11-08 Abbott Point of Care Canada Limited
  • Warning Letter 2017-04-12 Abbott Medical
  • Warning Letter 2015-09-30 St. Jude Medical
  • Warning Letter 2013-01-10 Abbott Medical
  • Warning Letter 2012-10-10 Alere San Diego, Inc.
  • Warning Letter 2012-06-05 St. Jude Medical
  • Warning Letter 2012-01-03 Thoratec LLC
  • Warning Letter 2010-12-22 Abon Biopharm (Hangzhou) Co., Ltd.
  • Warning Letter 2010-07-02 Abbott Diabetes Care, Inc.
  • NAI 2025-12-10 Alere San Diego Inc. · 0 citations
  • OAI 2025-10-23 Abbott Diabetes Care, Inc. · 2 citations
  • NAI 2025-09-19 Abbott Medical · 0 citations
  • VAI 2025-05-30 Thoratec LLC · 2 citations
  • NAI 2025-05-15 St Jude Cardiology Division Incorporated · 0 citations
  • NAI 2025-02-21 Abbott Medical · 0 citations
  • NAI 2024-09-19 Abbott Point of Care Canada Limited · 0 citations
  • NAI 2024-08-16 Ameditech Inc · 0 citations
  • NAI 2024-08-13 St. Jude Medical · 0 citations
  • VAI 2024-06-28 Abbott · 3 citations
  • NAI 2024-04-25 Abbott Medical Costa Rica Ltda · 0 citations
  • NAI 2023-12-08 Abbott Vascular · 0 citations
  • OAI 2023-11-16 Abbott Vascular · 0 citations
  • NAI 2023-11-16 Abbott Diabetes Care, Inc. · 0 citations
  • NAI 2023-10-27 Abbott Vascular Inc · 0 citations
  • VAI 2023-06-28 Abbott Medical · 3 citations
  • VAI 2023-03-21 BIGFOOT BIOMEDICAL · 2 citations
  • VAI 2023-01-27 Abbott Molecular, Inc. · 2 citations
  • NAI 2022-12-14 Cardiovascular Systems Inc · 0 citations
  • VAI 2022-11-23 Abbott Medical · 1 citations