Z-0077-2007

VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS...

Name: Z-0077-2007 VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS...
Creator: Ortho-Clinical Diagnostics
Published: 2006-03-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2006-03-06 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems (Catalog # ENGEN). VITROS WorkCentre is Ortho-Clinical Diagnostics, Inc.''s... on 2006-03-06. The reason FDA records is "Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0077-2007
Status: Terminated
Initiated: 2006-03-06
Posted: 2006-10-27
Terminated: 2008-06-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)
FDA 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 in commerce: 3 Domestic, 6 Foreign
Distribution: Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.
Product codes and lots: Catalog # 6802159

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)