Official recall record
A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dr
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2024-09-18
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00381933021011
- Brand on record
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.