Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84840

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

Open FDA event record

Event summary

Timeline bucket
January 21, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Polymer Technology Systems, 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

PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for professional use to determine if an individual has been exposed to nicotine.

Z-1438-2020
Recall number
Z-1438-2020
Initiated
January 21, 2020
Classification
Class II
Status
Terminated
Quantity
6790

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.

Code information

1811715 1831313 1831324 1831325

Distribution pattern

Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.