Exact FDA event identifier

Event 67818

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

Open FDA event record

Event summary

Timeline bucket: March 26, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Branan Medical Corporation

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

ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only.

Z-1508-2014

Recall number: Z-1508-2014
Initiated: March 26, 2014
Classification: Class II
Status: Terminated
Recalling firm: Branan Medical Corporation
Quantity: 9,800 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

May be labeled with incorrect result interpretation graphics on the ToxCup lid label.

Code information

Lot Numbers: O0056 O0067 N0854 O0013 O0099 O0100 O0057 O0059 O0060 O0079

Distribution pattern

Worldwide Distribution: US (nationwide) and country of Canada.