FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0077-2007
- Recalling firm
- Ortho-Clinical Diagnostics
- 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.
- Status
- Terminated
- Initiated
- 2006-03-06
- Posted
- 2006-10-27
- Terminated
- 2008-06-18
- 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.
- Lot, serial or model codes
- Catalog # 6802159
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- Firm FEI
- 1000136573
- Firm city
- Rochester
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28