PTS Test Strips Recalled for Under-Recovery Against Reference Method
Polymer Technology Systems is recalling specific CHOL+HDL+GLU test strips because they show under-recovery when tested against a reference method.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect (under-recovery) without reported adverse health consequences, fitting the Moderate criteria for low-risk issues or voluntary precautionary actions.
Plain-English summary
Polymer Technology Systems, Inc. is recalling PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers. The recall involves Lot Number I502 (UDI 00381932412018). A total of 6,467 units were distributed.
The recall was initiated because the test strips are showing an under-recovery when tested against a reference method. This indicates that the test results may not accurately reflect the true values for cholesterol, HDL, and glucose.
The products were distributed to the following US states: CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, and WI. They were also distributed to the following foreign countries: Australia, Belgium, Indonesia, Italy, Poland, South Africa, UK, and Vietnam. Users should stop using the affected test strips and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
- Manufacturer
- Polymer Technology Systems, Inc.
- Hazard
- Affected units
- 6,467
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)
- Lot Number I502
- UDI 00381932412018
Distribution
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