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Terminated

SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,

FDA Recall Z-2865-2017 · Posted None

Recalling FirmSoft Computer Consultants, Inc.
Recall StatusTerminated
Product CodeNSX
Date Initiated2017-05-31
Date Terminated2020-08-04
Product Quantity18 units

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.

Firm 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.

Root Cause

Use error

Distribution Pattern

US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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