The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484; 2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.
- 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:
- Sysmex Corporation
- Reason for Recall:
- There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
Product Codes/Lot Numbers:
1) Model: XN-10; Catalog Number: AP795756; Serial Numbers: 111001-15483 except 15287, 15298, 15308, 15408, 15442, 15454, 15470 and 15484; 2) Model: XN-20; Catalog Number: AE797961; Serial Numbers: 11001-12118 except 11960, 12039, 12078, 12114, and 12117.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1945-2016