Recall Z-0223-2025 ยท LCP Assay, Glycosylated Hemoglobin
Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
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.
| Date | Oct 24, 2024 (initiated Sep 18, 2024) |
| Status | Completed |
| Reason | 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 activi |
| 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 |
| Quantity | 2,452 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090413 | A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC Bayer Healthcare, LLC, May 14, 2009 |