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FDA device recall Z-0223-2025 · posted 2024-10-24 · Completed

Recall details

Recalling firm

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

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.

Action taken

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).

Root cause

Under Investigation by firm

Status

Completed

Product code

LCP

Quantity affected

2,452 units

Distribution

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

Date initiated

2024-09-18

Date posted

2024-10-24

Location

Whitestown, IN

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