A1CNow+ Multi-Test HbA1c System consists of (1) a… recallZ-0223-2025 · Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. · initiated Sep 18, 2024

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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).

Recall details

Recall number

Z-0223-2025

Status

Completed

Initiated by the company

Sep 18, 2024

Posted by the FDA

Oct 24, 2024

Recalling firm

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

Quantity

2,452 units

Product code

LCP

FDA submissions

K090413

Distribution

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

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• A1CNow®+ Multi-UseTest System (20 count) 3021

  Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN
  1 recall11 reports

Other devices under the same FDA submission

3 devices cleared under K090413 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• A1CNow® Self Check Test System 3070

  Polymer Technology Systems, Inc. · ASSAY, GLYCOSYLATED HEMOGLOBIN
  6 reports
• Well at Walgreens 3056

  Walgreen CO. · Assay, Glycosylated Hemoglobin
  1 report
• ReliOn™ 2CT A1C Meter 3055

  Wal-Mart Stores, Inc. · Assay, Glycosylated Hemoglobin
  1 report