PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions
PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III recall for incorrect instructions packaged with the product. This is a documentation error with no reported illnesses or injuries. The moderate score reflects that proper instructions are essential for correct operation of diagnostic test strips.
Plain-English summary
Polymer Technology Systems, Inc. (dba PTS Diagnostics, Inc.) is recalling PTS Panels CHOL+GLU Test Strips (REF 1765, lot A202) due to incorrect instructions for use that were packaged with the final product.
The recalled test strips were distributed worldwide, including in the United States, Japan, and Russia.
Users and healthcare providers in possession of these test strips should verify correct usage instructions before testing to ensure accurate results.
The recalled product
- Product
- PTS Panels CHOL+GLU Test Strips (REF 1765)
- Hazard
Distribution
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