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U.S. Department of Health and Human Services

Class 2 Device Recall Instrument Manager software

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 Class 2 Device Recall Instrument Manager softwaresee related information
Date Initiated by FirmMay 11, 2009
Date PostedOctober 21, 2011
Recall Status1 Terminated 3 on October 25, 2011
Recall NumberZ-0083-2012
Recall Event ID 52105
510(K)NumberBK080052 
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductInstrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09. It is a stand-alone software package that provides connectivity between laboratory instruments and Laboratory Information Systems, aiding the flow of laboratory information, including test orders and results, specimen information, and patient information. Instrument Manager also provides data management functions that aid in the interpretation and management of laboratory results. The Instrument Manager software is put on a CD which is distributed in a box. User documentation consists of user manuals, PDF copies of which are on the CD Intended to be used by trained laboratory personnel as an aid in laboratory instrument interfacing and laboratory data management.
Code Information S/W Versions 8.05, 8.06, 8.07, 8.08 and 8.09.
Recalling Firm/
Manufacturer		 Data Innovations, Inc.
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
For Additional Information ContactDave Potter
802-264-3411
Manufacturer Reason
for Recall		The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result".
FDA Determined
Cause 2		Software design
ActionData Innovations sent an "IMPORTANT PRODUCT NOTICE" dated May 11, 2009 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter offers temporary workarounds for customers to use until corrected versions of the software is complete. Versions of the corrections will be provided on a staggered schedule. Customers will be notified by e-mail. Questions regarding this notice are directed to Support at 802-658-1955.
Quantity in Commerce188
DistributionUSA (nationwide) and the country of Canada.
Total Product Life CycleTPLC 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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