🔍 RecallPedia

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

Class I - Dangerous
🏥 Medical Devices Recalled: May 20, 2014 SCC Soft Computer Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
SCC Soft Computer
Reason for Recall:
The interface fails to send abnormal flags for Reference Lab test results.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

Product Codes/Lot Numbers:

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1038-2015

Related Recalls

SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

SCC Soft Computer

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When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.

Jan 29, 2014 Diagnostic Equipment View Details →

SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data.

SCC Soft Computer

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On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of results from the Sysmex series of Hematology instruments to display under the same order on the instrument menu.

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