CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153
- 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
- Reason for Recall:
- A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CVS Health At Home A1C Test Kit, Software Version Revision D, REF Number 3059
Product Codes/Lot Numbers:
Lot Numbers: 1606319 1606405 1606460 1610622 1610910 1611163 1618153
Distribution:
Distributed in: US, AR, CA, FL, IL, IN, KY, MN, NC, NJ, NY, OH, PA, RI, TN, UT, VA, WA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0686-2020
Related Recalls
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
PTS Diagnostics CardioChek Plus Professional Analyzer, New analyzer, boxed, with carrying case, Reference Numbers 2700
Polymer Technology Systems
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.
Henry Schein CardioChek Starter Kit, Reference Number 4060 HS, 570-1036
Polymer Technology Systems
One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.