SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Class I - DangerousWhat Should You Do?
- Check if you have this product: Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
- 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:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Product Codes/Lot Numbers:
Versions 4.5.4.3, 4.5.4.5, 4.5.4.6, 4.5.4.8, 4.5.4.9, 4.5.4.20, 4.5.4.30, 4.5.4.40, 4.5.5.0, 4.5.5.10, and 4.5.5.20
Distribution:
Distributed in: US, CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2865-2017
Related Recalls
Software showing wrong results reported, PDF not match HIS.
SoftCytogenetics
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Software is given wrong results going out to HIS on test that had reruns.
Software error. Potential for incorrect results