FDA Medical Device Recalls (openFDA)
Soft Computer Consultants, Inc.: SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained
- Recall number
- Z-2865-2017
- Recalling firm
- Soft Computer Consultants, Inc.
- Product
- SoftLab Software Laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained,
- Status
- Terminated
- Initiated
- 2017-05-31
- Posted
- not on file
- Terminated
- 2020-08-04
- 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 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
- 18 units
- Distribution
- US Distribution to states of: CA, IL, LA, MA, MD, MI, MN, NJ, NY, PA, and TX.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NSX
- Firm FEI
- 1000307651
- Firm city
- Clearwater
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28