PTS Glucose Test Strips Recalled for Under-Recovery of Glucose
Polymer Technology Systems is recalling PTS Glucose Test Strips because internal testing showed under-recovery of glucose, which could lead to inaccurate readings.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classifies this as a Class II recall, and the source text explicitly states the hazard could result in a low to moderate health risk, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Polymer Technology Systems, Inc. is recalling PTS PANELS Glucose Test Strips used with CardioChek Brand Analyzers. The recall was initiated after an internal investigation demonstrated under-recovery for glucose when tested against a reference method.
The affected product is used by healthcare professionals and individuals with diabetes to measure glucose in whole blood. The recall covers 7,048 total units, with 3,499 units distributed in the United States, including Puerto Rico. The product was also distributed worldwide to the UK, Chile, England, Belgium, Italy, Turkey, Lithuania, Latvia, Egypt, Spain, Hokkaido, Sweden, Mexico, UAE, Korea, Israel, Malaysia, Australia, Portugal, Poland, Slovenia, and St. Kitts and Nevis.
The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences. The source text notes that the under-recovery could result in a low to moderate health risk. Consumers and healthcare professionals should stop using the affected test strips and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- PTS PANELS, Glucose Test Strips for use with CardioChek Brand Analyzers Product Usage: used by healthcare professionals and individuals with diabetes to measure glucose in whole blood
- Manufacturer
- Polymer Technology Systems, Inc.
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 (1)
- U1117
Distribution
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