RecallWatchUSA

Home / Recalls / Medical Devices

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 ca

Recalled October 30, 2024 · FDA recall Z-0223-2025 · Polymer Technology Systems, Inc.

Hazard
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. · FDA Class II
Units
2,452 units
Sold at
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.

Description

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.

Product
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.
Manufacturer(s)
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

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 ca | RecallWatchUSA