epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00630414605760 00630414606095 00630414605821 00630414605838 00630414605678 00630414605814 00630414612447 00630414631028; All serial numbers.
- 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 Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS Host and Delete Blood Tests feature is enabled, the results that are generated at the time of testing are correct; however, when this issue occurs, results that are printed, saved and/or transferred to a data manager, may include unselected analytes that are from a previous patient or QC test. The worst possible outcome may result in a failure to diagnose hyperkalemia, due to an erroneous depressed potassium level or inappropriate treatment to hyperglycemia due to erroneous glucose reading.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Product Codes/Lot Numbers:
UDI-DI: 00630414605760 00630414606095 00630414605821 00630414605838 00630414605678 00630414605814 00630414612447 00630414631028; All serial numbers.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0601-2024
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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.