Polymer Technology Systems, Inc.: Medical Device Recall in 2012 - (Recall #: Z-1903-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 15, 2012

Date Posted: July 4, 2012

Recall Number: Z-1903-2012

Event ID: 61966

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.

Status: Terminated

Product Quantity: 1650 vials

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.

Voluntary or Mandated:

Voluntary: Firm initiated