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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84264

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

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Event summary

Timeline bucket
March 15, 2016
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 Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers

Z-0741-2020
Recall number
Z-0741-2020
Initiated
March 15, 2016
Classification
Class II
Status
Terminated
Quantity
6467

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This lot of test strips is showing an under-recovery when tested against a reference method.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

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Inspect official wording and provenance

Reason for recall

This lot of test strips is showing an under-recovery when tested against a reference method.

Code information

Lot Number I502, UDI 00381932412018

Distribution pattern

The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. The products were distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam.