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U.S. Department of Health and Human Services

Class 2 Device Recall Sunquest Laboratory Versions 6.4

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  Class 2 Device Recall Sunquest Laboratory Versions 6.4 see related information
Date Initiated by Firm December 05, 2011
Date Posted August 24, 2012
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-2270-2012
Recall Event ID 62708
Product Classification Calculator/data processing module for clinical use. - Product Code JQP
Product Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
Code Information Versions 6.4 and later
Recalling Firm/
Manufacturer		 Sunquest Information Systems, Inc.
250 S Williams Blvd
Tucson AZ 85711-4472
For Additional Information Contact
520-570-2252
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Sunquest sent a recall letter dated December 5, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your reply to this email message serves as verification you have received, read, understood and/or followed instructions outlined in the attached Product Safety Notification. Your reply assists Sunquest Information Systems to satisfy our obligation to Regulatory Agencies. Please note in your email reply if your site will not be requesting the software correction. If your site plans to request the software correction, please follow the directions noted on the attached PSN. Further questions please call (520) 570-2347.
Quantity in Commerce 127 sites
Distribution Worldwide Distribution -- USA (nationwide) and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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