SCC Soft Computer recalls SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, an…

Recall date

November 26, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1065-2015

FDA classification

Class II

Brand / firm

SCC Soft Computer

Sold / distributed

Distribution US Nationwide and CANADA.

Why it was recalled

Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0