Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
- 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:
- Life Technologies Corporation
- Reason for Recall:
- The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reporting of ROS1 fusion. If a physician relies on a false negative result, crizotinib could be improperly excluded from the patient's treatment regimen.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
Product Codes/Lot Numbers:
Lot 1705001 UDI: (01)10190302006385(17)180220(10)1705001(240)A32441
Distribution:
Distributed in: AZ, CA, NC, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1480-2018
Related Recalls
Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems exploitation of the vulnerability by a threat actor may allow them to alter settings, configurations, software, or data on the instrument
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.
COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.