Recalls / —
—#48146
Product
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.
- FDA product code
- JQP — Calculator/Data Processing Module, For Clinical Use
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Catalog # 6802159
Why it was recalled
Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Ortho-Clinical Diagnostics
- Address
- 100 Indigo Creek Drive, Rochester, New York 14626
Distribution
- Distribution pattern
- Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.
Timeline
- Recall initiated
- 2006-03-06
- Posted by FDA
- 2006-10-27
- Terminated
- 2008-06-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #48146. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.