Recall Z-0073-2013— Sunquest Information Systems, Inc.
Class III · Terminated
Class III FDA medical device recall by Sunquest Information Systems, Inc., initiated 2011-11-15, terminated 2012-10-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.. Reason: Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10..
- Recalling firm
- Sunquest Information Systems, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2011-11-15
- Terminated
- 2012-10-19
- Firm location
- Tucson, AZ, United States
Product description
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Reason for recall
Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the Online Entry (OEM) application for a subtest whose subcolumn number on the instrument online string is divisible by 10.
Data sourced from openFDA. This site is unofficial and independent of the FDA.