Whitestown, IN, United States
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. recalls
2 recalls recorded since 2018, most recently on 18 September 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Completed Class II Medical devices
- Recall started
- 18 September 2024
- Reason
- 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.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0223-2025
- A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample
Completed Class III Medical devices
- Recall started
- 16 August 2022
- Reason
- Incorrect instructions for use were packaged into the final product.
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of Virginia and the countries of Japan and Russia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1741-2022
- PTS Panels CHOL+GLU Test Strips (REF 1765)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.