Z-2270-2012 Class II Terminated
FDA device recall Z-2270-2012 was initiated by Sunquest Information Systems, Inc. on December 5, 2011 and is designated Class II. Reason for recall: 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 Nu… The recall status is terminated (terminated August 27, 2012). Affected quantity: 127 sites.
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2012
- Initiation Date
- December 5, 2011
- Termination Date
- August 27, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 127 sites
Product Description
Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution -- USA (nationwide) and the country of Canada.
Code Information
Versions 6.4 and later