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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86279

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 24, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
DNA Genotek Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

PrepIT Q2A Kit, Model PT-Q2A-96 containing component reagent AG (PT-QAG-96) 1.4mL and ST (PT-QST-96) 2.9mL - Product Usage: used for the removal of SDS and other inhibitors from samples collected using DNA Genotek oral sample collection kits.

Z-3004-2020
Recall number
Z-3004-2020
Initiated
June 24, 2020
Classification
Class III
Status
Terminated
Recalling firm
DNA Genotek Inc.
Quantity
74

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reagents were shipped to customers after the Use by data indicated on its labeling.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reagents were shipped to customers after the Use by data indicated on its labeling.

Code information

Lot PT-Q2A WE11

Distribution pattern

Worldwide distribution - US Nationwide distribution including in the states of CA, MA, MD, MN, NY, PA, and TX. The country of China.