Class 2 Device Recall A1CNow (Professional Use)

• Date Initiated by Firm: September 18, 2024
• Date Posted: October 24, 2024
• Recall Status: Completed
• Recall Number: Z-0223-2025
• Recall Event ID: 95416
• 510(K)Number: K090413
• Product Classification: Assay, glycosylated hemoglobin - Product Code LCP
• 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.
• Code Information: UDI-DI: 00381933021011 Lot Numbers: 9331803, 2323019
• FEI Number: 3002698769
• Recalling Firm/ Manufacturer: Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.; 4600 Anson Blvd; Whitestown IN 46075-4489
• For Additional Information Contact: SAME; 317-870-5610
• Manufacturer 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 Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• 510(K) Database: 510(K)s with Product Code = LCP