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U.S. Department of Health and Human Services

Class 2 Device Recall SoftLab

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 Class 2 Device Recall SoftLabsee related information
Date Initiated by FirmMay 31, 2017
Create DateAugust 02, 2017
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-2865-2017
Recall Event ID 77669
Product Classification Software, transmission and storage, patient data - Product Code NSX
ProductSoftLab 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
FEI Number 1000307651
Recalling Firm/
Manufacturer		 Soft Computer Consultants, Inc.
5400 Tech Data Dr
Clearwater FL 33760-3116
For Additional Information ContactTechnical Support 24/7
800-763-8522
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.
FDA Determined
Cause 2		Use error
ActionThe 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 Commerce18 units
DistributionUS Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
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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