binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
- 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:
- Binx Health, Inc.
- Reason for Recall:
- May not meet the declared performance characteristics for the detection of Chlamydia trachomatis (CT) within the labeled expiry period, potential to produce either false negative CT or positive CT results
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
binx io CT/NG Assay- Single-use Cartridge for the qualitative detection of Chlamydia trachomatis and Neisseria gonorrhoeae Ref: 1.002.101
Product Codes/Lot Numbers:
UDI: 5060441760050 Lot Number: 00210869309 Exp Date: March 31, 2023
Distribution:
Distributed in: US, PA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1626-2023