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Class 2 Device Recall SoftLab |
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Date Initiated by Firm |
May 31, 2017 |
Create Date |
August 02, 2017 |
Recall Status1 |
Terminated 3 on August 04, 2020 |
Recall Number |
Z-2865-2017 |
Recall Event ID |
77669 |
Product Classification |
Software, transmission and storage, patient data - Product Code NSX
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Product |
SoftLab Software
Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Soft Computer Consultants, Inc. 5400 Tech Data Dr Clearwater FL 33760-3116
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For Additional Information Contact |
Technical Support 24/7 800-763-8522
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Manufacturer 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.
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FDA Determined Cause 2 |
Use error |
Action |
The firm, SCC Soft Computer, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 05/31/2017to its consignees. The letter described the product, problem and actions to be taken. The consignees were informed that the issue will be corrected with a mandatory hotfix. The Consignees were instructed to acknowledge receipt of the recall notice by signing the recall notice and calling Technical Support at 800-763-8522 to grant permission to load the hotfix.
For questions or concerns, please call 800-763-8522 Technical Support, available 24/7, and for any adverse reactions/quality problems experienced with the use of this product are to be reported to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. |
Quantity in Commerce |
18 units |
Distribution |
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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