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Accutest iFOBT - Specimen Collection Tubes

Model CS630 · JANT PHARMACAL CORPORATION · DI 10763924630551

KHE — Reagent, Occult Blood · Class II · 21 CFR 864.6550

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (4)

InitiatedRecall #ClassStatusReasonLink basis
2011-03-21Z-2108-2011TerminatedPotential for false negatives test results and negative/faint positive controlsk number procode
2011-03-21Z-2109-2011TerminatedPotential for false negatives test results and negative/faint positive controlsk number procode
2011-03-21Z-2110-2011TerminatedPotential for false negatives test results and negative/faint positive controlsk number procode
2011-03-21Z-2111-2011TerminatedPotential for false negatives test results and negative/faint positive controlsk number procode

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.

11222019-08: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device08100107080803050905
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0802
2020-1001
2021-0102
2021-0702
2021-0801
2022-0801
2024-0301
2025-0501
2025-0901
2026-0501
This device (reports/month)Average device in KHE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — JANT PHARMACAL CORPORATION

  • NAI 2016-11-03 Jant Pharmacal Corporation · 0 citations
  • NAI 2016-11-03 Jant Pharmacal Corporation · 0 citations
  • NAI 2014-10-15 Jant Pharmacal Corporation · 0 citations
  • NAI 2014-10-15 Jant Pharmacal Corporation · 0 citations
  • NAI 2011-11-08 Jant Pharmacal Corporation · 0 citations
  • NAI 2011-11-08 Jant Pharmacal Corporation · 0 citations