Reported Aug 22, 2012 · Terminated
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
Sunquest Information Systems, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sunquest Information Systems, Inc. · 250 S Williams Blvd · Tucson, AZ · 85711-4472
Is this the product you have?
- Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
- Lot codes and dates
- Version 6.3.0 and Later
- Amount recalled
- 103 sites
Where it was sold
- Nationwide
Why it was recalled
In Online Entry (OEx) there are two scenarios where a Test result from one container may file to a Test on another container. In order for this to occur: 1) Site parameter SIT 1,2,1,26 (3,217) [Restrict resulting of tests to owner container (<Y>/N)]=Y. 2) The Tests are ordered on the same accession number and 3) The Test codes are defined to have the same upload code as either replicate or
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sunquest Information Systems, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.