SoftCytogenetics
Class I - Dangerous 🏥 Medical Devices
Recalled: March 31, 2021 Soft Computer Consultants Other Medical Devices
Nationwide
What Should You Do?
- Check if you have this product: Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
- 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:
- Soft Computer Consultants, Inc.
- Reason for Recall:
- Software is given wrong results going out to HIS on test that had reruns.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SoftCytogenetics
Product Codes/Lot Numbers:
Versions: 4.1.11.20, 4.1.12.11 and 4.1.15.6
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2098-2021
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Software showing wrong results reported, PDF not match HIS.
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Display of lab results based on incorrect LOINC code/test descriptions for tests that were performed at a reference lab, saved incorrectly, and sent to systems that display the EMR.
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