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.
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, 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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