RegWardenFDA facility compliance records
Recall

Class II — Soft Computer Consultants, Inc.

Recalling firmSCC SOFT COMPUTER
Registered facilitySCC SOFT COMPUTER (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonSoftware error. Potential for incorrect results
ProductSoftbank software Product Usage: Decision support software for transfusion service. It keeps track of inventory from outside sources, multi-site inventory control, records of testing of units, and allows for record keeping for transfusion preparation.
Quantity189 total
DistributionWorldwide Distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WI, WV, and the countries of Hawaii and Puerto Rico Canada & Jamaica
Initiated2016-10-06
Classified2017-01-26
Terminated2019-08-21
Recall numberZ-1098-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Soft Computer Consultants, Inc. (Z-1098-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76046/

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