Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Class I - DangerousWhat Should You Do?
- Check if you have this product: Version 6.4.2
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- In GUI inquiry, searching by ID (CID) may return the wrong patient demographic data if the accession number associated to the CID is no longer inactive.
- 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 SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Product Codes/Lot Numbers:
Version 6.4.2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2229-2012
Related Recalls
Sunquest Laboratory, version 7.0 not available
Sunquest Information Systems
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.
Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later.
Sunquest Information Systems
The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately.
Sunquest Laboratory : intended for use by professionals working in a clinical laboratory.
Sunquest Information Systems
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.