Recall Z-0167-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Data Innovations, Inc.
Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R)
| Date | Nov 14, 2006 (initiated Aug 10, 2006) |
| Status | Terminated |
| Reason | Patient results may be associated with an incorrect specimen |
| Root cause | Other |
| Action | Data Innovations notified customers by an email listserv notification and by letter dated 8/17/06. A patch would be available on the website to be downloaded. |
| Quantity | 187 |
| Distribution | Worldwide distribution (USA and Canada) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.