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Terminated

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 Recall Z-0077-2007 · Posted 2006-10-27

Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeJQP
Date Initiated2006-03-06
Date Terminated2008-06-18
Product Quantity3 Domestic, 6 Foreign

Reason for Recall

Incorrect result calculations can occur (only affects derived results calculated by the VITROS WorkCentre)

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide distribution ---- USA including states of DE, TN, MI, and AZ and countries of United Kingdom and France.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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