Recall Z-0077-2007 ยท JQP Calculator/Data Processing Module, For Clinical Use
Ortho-Clinical Diagnostics
VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s branded version of Instrument Manager" developed & listed by Data Innovations, Inc. of South Burlington, VT. --- Ortho-Clinical Diagnostics, Rochester, NY.
| Date | Oct 27, 2006 (initiated Mar 6, 2006) |
| Status | Terminated |
| Reason | Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre) |
| Root cause | Other |
| Action | On 3/06/06, all domestic end-users were sent "URGENT PRODUCT CORRECTION NOTIFICATION" letters (dated 3/06/06) by fax and FedEx, informing the users of the problem. The users were also notified by phone. OCD also notified its affiliates in France and the UK of the issue for notifying their customers of the problem. |
| Quantity | 3 Domestic, 6 Foreign |
| Distribution | Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.