Recall Z-0083-2012 ยท JQP Calculator/Data Processing Module, For Clinical Use
Data Innovations, Inc.
Instrument 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
| Date | Oct 21, 2011 (initiated May 11, 2009) |
| Status | Terminated |
| Reason | The "previous result" retrieved from the Specimen Management Database may not be the most recent "previous result". |
| Root cause | Software design |
| Action | Data 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 | 188 |
| Distribution | USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| BK080052 | Not in our 510(k) copy |