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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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…
- Manufacturer
- Polymer Technology Systems, Inc.
- 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
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