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 c…

Recall date

September 18, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0223-2025

FDA classification

Class II

Brand / firm

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Japan, South Africa.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.