CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 071399 072985
- 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:
- Cytocell Ltd.
- Reason for Recall:
- The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in vitro diagnostics
Product Codes/Lot Numbers:
Lot Numbers: 071399 072985
Distribution:
Distributed in: US, CA, IL, MO, NY, PA, TX, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2134-2021
Related Recalls
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing.
An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has been created using the wrong coordinates.