Z-2865-2017Class II

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

Name: Z-2865-2017 SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by...
Creator: Soft Computer Consultants, Inc.
Published: 2017-05-31
License: https://open.fda.gov/license/

SCC Soft Computer / initiated 2017-05-31 / Terminated

FDA source

Soft Computer Consultants, Inc. began a recall of SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained on 2017-05-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2865-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-31
Posted: 2017-08-02
Terminated: 2020-08-04
Recalling firm: SCC Soft Computer
Product: SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
Product code: NSX
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 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 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2865-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2865-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-09	2017-08-02

Product code NSX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)