Recall Z-2270-2012— Sunquest Information Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Sunquest Information Systems, Inc., initiated 2011-12-05, terminated 2012-08-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry. Reason: 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..
- Recalling firm
- Sunquest Information Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-05
- Terminated
- 2012-08-27
- Firm location
- Tucson, AZ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.