ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot/Serial# PML0937
- 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:
- Horiba Instruments, Inc dba Horiba Medical
- Reason for Recall:
- Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
Product Codes/Lot Numbers:
Lot/Serial# PML0937
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0645-2013
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