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All product recalls associated with Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc..
Total Recalls
13
Past Year
0
Class I (Serious)
0
Most Recent
Sep 2024
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test results as components within each lot number are meant to be used together, and not mixed between lots. Therefore, the test results may possibly lead to Hemoglobin A1C positive or negative bias results. While the product is for monitoring only, over recovery with a higher than accurate value can be an indication for increased therapy; such as physical activity, weight reduction, meal management, pharmaceutical therapy.
Incorrect instructions for use were packaged into the final product.
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.