ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers of ADVIA 560 Hematology Systems
- 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 is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the installation of the systems. The database should only contain one record of a Sample ID number for any given time and date. If there are multiple records for the same Sample ID, it is possible that multiple results may be manually or automatically sent to the Laboratory Information System (LIS), printed or displayed on the results report screen.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Product Codes/Lot Numbers:
All serial numbers of ADVIA 560 Hematology Systems
Distribution:
Distributed in: US, CA, CO, FL, IL, MI, NJ, NY, OH, TX, WA, WI, WY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0723-2017
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