A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the mon...
FDA Recall #Z-0223-2025 — Class II — September 18, 2024
Product Description
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, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.
Reason for Recall
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.
Recalling Firm
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. — Whitestown, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2,452 units
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
Code Information
UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
Status
Completed
Voluntary / Mandated
Voluntary: Firm initiated