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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61966

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

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Event summary

Timeline bucket
May 15, 2012
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 Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended for the professional use for accurately and reproducibly measuring creatinine in human whole blood obtained from a finger stick sample

Z-1903-2012
Recall number
Z-1903-2012
Initiated
May 15, 2012
Classification
Class II
Status
Terminated
Quantity
1650 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

During a routine product investigation, a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and the meter provided a result of 0.08mg/dl, which is not the reportable measuring range for the CardioChek PA meter for the creatinine assay.

Code information

Cat No. 1720; and Lot number F103

Distribution pattern

Worldwide Distribution -- Nationwide Distribution including the states of CA and VA., and the countries of China, Poland, Ireland and France.