Data Foundry

Medical device recalls 2014

SCC SA HIS version 4 — Class II medical device recall Z-1573-2014

Terminated recall by SCC Soft Computer, reported 2014-05-21, distributed in IL. When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incompl

Recall numberZ-1573-2014
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmSCC Soft Computer, Clearwater, FL, United States
Recall initiated2014-01-29
Classified2014-05-09
Reported by FDA2014-05-21
Terminated2014-11-03
DistributedIL
Quantity1

Product

SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data processing and laboratory activities for microbiology and serology testing, for the purpose of storing, managing, querying, and reporting laboratory data.

Reason for recall

When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1573-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.