CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881, Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181
- 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:
- Siemens Healthcare Diagnostics has determined that the sample query function that includes Instrument or Instrument Group as search criteria may not return all samples from the Dimension Vista systems if onboard aliquot support rules are configured in the CentraLink system.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CentraLink" Data Management System; software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
Product Codes/Lot Numbers:
Product: Siemens CentraLink Data Management System, v14.0.5 Material Number (SMN)10811741, 10811742, 10811743, 10814298, 10814877, 10814880,10814881, Product: CentraLink Data Management System, v14.0.8 Material Number (SMN)10815474, 10816519, 10816520, 10816521, 10816522, 10816523, 10816524, 10817180, 10817181
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1957-2015
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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;
Siemens Healthcare Diagnostics
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.