Z-0223-2025Class II

A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a...

Name: Z-0223-2025 A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a...
Creator: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
Published: 2024-09-18
License: https://open.fda.gov/license/

Polymer Technology Systems / initiated 2024-09-18 / Completed

FDA source

Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. began a recall of A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips... on 2024-09-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed.

Recall record

Recall number: Z-0223-2025
Classification: Class II
Status: Completed
Initiated: 2024-09-18
Posted: 2024-10-24
Recalling firm: Polymer Technology Systems
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.
Product code: LCP Assay, Glycosylated Hemoglobin
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.
FDA root cause: Under Investigation by firm
Action: PTS Diagnostics issued Urgent Medical Device Recall letter on 9/18/24 via UPS or Email. Letter states reason for recall, health risk and action to take: 1. Return any product remaining in your control for replacement. 2. Distributors should immediately forward this notice and response form to all customers/users who may have received this product. 3. Acknowledge receipt of this instruction by completing the attached form, even if you do not have the affected product on hand. PTS would like to remind customers/distributors that professional use products are prescription use only in the United States, meaning that federal law restricts this device to sale by or on the order of a licensed healthcare professional. We highly encourage you to monitor the activities of your customers/resel lers. Actions that have been taken by PTS Diagnostics: PTS Diagnostics has investigated this al legation and cannot confirm its veracity based on our review of retention samples, batch records, or product on hand Because the customers purchased these products through an e-tailer/reseller, PTS does not know if the issue could have happened in the distribution channel. Contact Information: Thank you for your prompt action, and we apologize for any inconvenience this issue may have caused you and your facility. If you have any questions, please contact Customer Service directly, Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time at + 1 317-870-5610 or 877-870-5610 (U.S. toll-free).
Quantity in commerce: 2,452 units
Distribution: Worldwide distribution - US Nationwide and the countries of Japan, South Africa.
Product codes and lots: UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0223-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0223-2025	Class II	Completed	Voluntary: Firm initiated	2024-10-30	2024-10-24

Product code LCP

K090413Class IIA1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self ChecBayer Healthcare, LLC / cleared 2009-05-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)