🔍 RecallPedia

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

Class I - Dangerous
🏥 Medical Devices Recalled: November 15, 2011 Sunquest Information Systems Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Versions 6.4.0 and later
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Sunquest Information Systems, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.

Product Codes/Lot Numbers:

Versions 6.4.0 and later

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0073-2013

Related Recalls

Sunquest Laboratory, version 7.0 not available

Sunquest Information Systems

Class I - Dangerous

Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data.

Nov 3, 2011 Other Medical Devices Nationwide View Details →

Sunquest Laboratory Sunquest Laboratory is intended for use by professionals working in a clinical laboratory. Sunquest Laboratory is intended for use only by professionals who have received extensive training in the use of the software. Sunquest Laboratory is controlled via userdefined security levels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including: " Patient registration " Order entry and order modification " Specimen collection, verification, suitability, and distribution " Quality assurance checking " Workload recording " Billing charge capture " Standards and controls recording " Test order result inquiry and reporting Organism susceptibility and epidemiology records " Microbiology culture direct examination and observation recording " Outreach clients, specimens, and results " Client-specific reporting capabilities " Inbound client service request tracking " Historical data Clients that use the Sunquest Blood Bank system should refer to the intended use statement found in the Blood Bank System Overview Users Guide.

Sunquest Information Systems

Class I - Dangerous

Sunquest is recalling Sunquest Laboratory versions 6.1.0125 through 6.1.0139, 6.2.1, 6.2.2, 7.0, and 7.0.1 because when the Windows-based merge application is used and the "Event merge across patients" option is used, a receiving system (for example a HIS or CoPath system) may interpret the event merge as a full patient merge. This occurs because a trigger from the Laboratory system for the event

Mar 15, 2012 Diagnostic Equipment Nationwide View Details →