SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Recall
- Recall Number
- Z-2865-2017
- Event Number
- 77669
- Firm
- Soft Computer Consultants, Inc.
- FEI Number
- 1000307651
- Product Code
- NSX
- Status
- Terminated
- Root Cause
- Use error
- Initiated
- May 31, 2017
- Terminated
- August 4, 2020
- Address
- 5400 Tech Data Dr, Clearwater, FL, 33760-3116
Description
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
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.
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.
US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
18 units