A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic ca
Summary
The FDA issued a Class II for A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encase by Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.. Reason: The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system bo.
Details
Source
Device Recall
External ID
Z-0223-2025
Action Date
2024-10-30
Status
Completed
Category
device
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.
Lot/Code Info: UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
Quantity Affected: 2,452 units
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.
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-18
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 253 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. have FDA actions?
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0223-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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