Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.: Medical Device Recall in 2024 - (Recall #: Z-0223-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 18, 2024

Date Posted: October 30, 2024

Recall Number: Z-0223-2025

Event ID: 95416

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.

Status: Completed

Product Quantity: 2,452 units

Code Information:

UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated