Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: (01)15099590707118, All DxA 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:
- Beckman Coulter Biomedical GmbH
- Reason for Recall:
- A software defect in the DxA Automation System may cause tests to be run on patient samples in tube types not compatible with the requested test, leading to erroneous patient results
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 16A, 50/60HZ, RxOnly
Product Codes/Lot Numbers:
UDI-DI: (01)15099590707118, All DxA serial numbers
Distribution:
Distributed in: US, AL, CA, FL, IL, IN, KY, MI, MN, MO, NE, NJ, NV, NY, OH, PA, SC, TX, WI, WV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2144-2023
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