VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ort
FDA device recall Z-0077-2007 · posted 2006-10-27 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JQP
- Quantity affected
- 3 Domestic, 6 Foreign
- Distribution
- Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.
- Date initiated
- 2006-03-06
- Date posted
- 2006-10-27
- Date terminated
- 2008-06-18
- Location
- Rochester, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.