PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number I502, UDI 00381932412018
- 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.
- Reason for Recall:
- This lot of test strips is showing an under-recovery when tested against a reference method.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Product Codes/Lot Numbers:
Lot Number I502, UDI 00381932412018
Distribution:
Distributed in: US, CA, CT, FL, IN, MA, MD, MI, MN, NC, NJ, NM, NY, OR, PA, TN, WI, UK
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0741-2020
Related Recalls
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
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