PTS Panels CHOL+GLU Test Strips (REF 1765)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.
- Reason for Recall:
- Incorrect instructions for use were packaged into the final product.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- completed
Product Information
Full Description:
PTS Panels CHOL+GLU Test Strips (REF 1765)
Product Codes/Lot Numbers:
Complete UDI: (01)00381931765016(17)230627(10)A202 UPC Code: 381931765016 lot A202
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1741-2022
Related Recalls
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.