Recall Z-2865-2017 ยท NSX
Soft Computer Consultants, Inc.
SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
| Date | May 31, 2017 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 experie |
| Quantity | 18 units |
| Distribution | US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.