Reported Aug 29, 2012 · Terminated
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
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 Product Usagefor clinical use
- Lot codes and dates
- Version 6.4.2
- Amount recalled
- 47 sites
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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