FDAClass IIFebruary 11, 2015

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is recall

SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.

Why was SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is recalled?

The interface fails to send abnormal flags for Reference Lab test results.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

4.0.7.0: released 12/13/13 - present 4.0.7.1: released 02/28/14 - present

Product
SoftLab with SA HIS versions 4.0.7.0-4.0.7.1 SoftLab is a laboratory information system to be used in a medical research or clinical laboratory.
Recalling firm
SCC Soft Computer
Quantity
48
Distribution
Distributed US (nationwide) in the states of OH, GA, NJ, WI, FL, NH, IL, NY, IN, CA, AL, VA, MO, MI, KY, MA, PA, CO, ME, TN, WA, MN, SD, LA, NC, and NV and the country of Canada.
Recall date
February 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls