PTS Diagnostics recalls A1CNow+ Multi-Test HbA1c System due to inaccurate test results from non-matching cartridge and analyzer codes. Affected units have specific lot numbers and may require replacement to ensure accurate blood sugar monitoring.
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.
PTS Diagnostics is recalling its A1CNow+ Multi-Test HbA1c System because using cartridges and analyzers with non-matching codes can cause inaccurate test results. This could lead to incorrect blood sugar readings, which might affect diabetes management decisions.
The system uses cartridges and analyzers that must match specific codes to work correctly. If codes don't match, the test results may be inaccurate, potentially leading to incorrect blood sugar readings.
People who own or use the A1CNow+ Multi-Test HbA1c System for blood sugar monitoring are affected. Those with diabetes who rely on accurate test results are most at risk.
Check for the lot numbers 9331803 or 2323019 on the product box. The product includes a semi-disposable plastic monitor, a plastic cartridge, and a sample dilution kit.
Look for lot numbers 9331803 or 2323019 on the product box to confirm if it's affected.
PTS Diagnostics received complaints that cartridges and analyzers with non-matching codes cause inaccurate test results, which could lead to incorrect blood sugar readings.
Inaccurate test results might lead to incorrect decisions about treatment, such as physical activity, weight reduction, or medication adjustments.
Check the product box for lot numbers 9331803 or 2323019. If affected, stop using it and contact PTS Diagnostics for a replacement.
We’ve drafted a message you can send PTS Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-0223-2025 — PTS Diagnostics PTS Diagnostics Hello, I own a PTS Diagnostics that is covered by recall Z-0223-2025 from PTS Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
