Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry

FDA device recall Z-2270-2012 · posted 2012-08-24 · Terminated

Recall details

Recalling firm

Sunquest Information Systems, Inc.

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.

Action taken

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.

Root cause

Software design

Status

Terminated

Product code

JQP

Quantity affected

127 sites

Distribution

Worldwide Distribution -- USA (nationwide) and the country of Canada.

Date initiated

2011-12-05

Date posted

2012-08-24

Date terminated

2012-08-27

Location

Tucson, AZ