Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Software in V 1.14.2 and lower.
- 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:
- Siemens Healthcare Diagnostics, Inc.
- Reason for Recall:
- Multiple Issues Identified in Atellica Solution System Software in V 1.14.2 and lower in: Atellica¿ IM 1300 Analyzer Atellica¿ IM 1600 Analyzer;Atellica¿ CH 930 Analyzer; Atellica¿ Sample Handler Prime
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
Product Codes/Lot Numbers:
Software in V 1.14.2 and lower.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0783-2019
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Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
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The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
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The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode scanner, the instrument will not correctly recognize the position of tubes within the allergen holder wedge.