FDAFDA · Food and drugs·Recall number Z-2270-2012
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Published September 5, 2012 · Recall initiated: December 5, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory versions 6.4 and later while using Microbiology Result Entry (MRE), the specimen ribbon containing the Accession Number (AN) and the Battery Name may be missing or contain the wrong information.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sunquest Information Systems, Inc.
- Distributor
- Worldwide Distribution -- USA (nationwide) and the country of Canada.
- Lot
- Versions 6.4 and later
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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