Recall Z-1903-2012— Polymer Technology Systems, Inc.

Name: FDA recall Z-1903-2012
Creator: U.S. Food and Drug Administration
Published: 2012-05-15

Class II · Terminated

Class II FDA medical device recall by Polymer Technology Systems, Inc., initiated 2012-05-15, terminated 2012-07-20. It names one FDA 510(k) clearance: K010456. Product: 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. Reason: 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..

Recalling firm: Polymer Technology Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-05-15
Terminated: 2012-07-20
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K010456 — BIOSCANNER CREATININE TEST STRIPSPolymer Technology Systems, Inc.·cleared 2001-06-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.