The Recall Desk
ModerateFDA (Devices)·Z-1903-2012·Announced 2012-07-04

Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips

Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a measurement error discovered during a routine investigation without reporting any patient injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Polymer Technology Systems, Inc. is recalling 1,650 vials of PTS Panels Creatinine Test Strips, Catalog No. 1720, Lot F103. These test strips are intended for professional use to measure creatinine in human whole blood obtained from a finger stick sample, which is used in the diagnosis and treatment of renal diseases and monitoring of renal dialysis.

The recall was initiated after a routine product investigation revealed that a creatinine sample with a value less than 1.0 mg/dl was tested on a version 2.60 CardioCek PA meter and provided a result of 0.08 mg/dl. This result is not within the reportable measuring range for the CardioChek PA meter for the creatinine assay.

The affected product was distributed worldwide, including nationwide distribution in the United States (specifically California and Virginia) and in China, Poland, Ireland, and France. Users should stop using the affected test strips and contact Polymer Technology Systems for further instructions.

The recalled product

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 f
Manufacturer
Polymer Technology Systems, Inc.
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
1,650

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Cat No. 1720
  • and Lot number F103

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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