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AB-Trol 3 Coagulation Control

Model 5183 · HELENA LABORATORIES CORPORATION · DI M52551830

GGN — Plasma, Coagulation Control · Class II · 21 CFR 864.5425

UDILibrary device dossier · generated 2026-09-15 · 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.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — HELENA LABORATORIES CORPORATION

  • VAI 2018-12-14 Helena Laboratories, Corp. · 4 citations
  • VAI 2018-12-14 Helena Laboratories, Corp. · 4 citations
  • OAI 2017-07-21 Helena Laboratories, Corp. · 8 citations
  • OAI 2017-07-21 Helena Laboratories, Corp. · 8 citations
  • NAI 2017-07-14 Helena Laboratories, Inc · 0 citations
  • NAI 2017-07-14 Helena Laboratories, Inc · 0 citations
  • VAI 2013-03-01 Helena Laboratories, Inc · 1 citations
  • VAI 2013-03-01 Helena Laboratories, Corp. · 9 citations
  • VAI 2013-03-01 Helena Laboratories, Inc · 1 citations
  • VAI 2013-03-01 Helena Laboratories, Corp. · 9 citations
  • VAI 2010-10-29 Helena Laboratories, Corp. · 0 citations
  • VAI 2010-10-29 Helena Laboratories, Corp. · 0 citations
  • NAI 2010-10-28 Helena Laboratories, Inc · 0 citations
  • NAI 2010-10-28 Helena Laboratories, Inc · 0 citations