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Polymer Technology Systems, Inc. Recalls
2 recalls on record · September 21, 2022 to October 30, 2024 · Medical Devices
Recalls by year
22
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
October 30, 2024Medical DevicesFDA
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recalls A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic ca
Hazard: 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.
September 21, 2022Medical DevicesFDA
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recalls PTS Panels CHOL+GLU Test Strips (REF 1765)
Hazard: Incorrect instructions for use were packaged into the final product.