Device recall

Z-0077-2007: VITROS WorkCentre, Catalog # 6802159, using enGen" Series Automation Systems…

FDA device recall · Class III · Ortho-Clinical Diagnostics

Key facts

Recall number (Z-number) Z-0077-2007
Recall event 36184
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…
Product code JQP
Recalling firm Ortho-Clinical Diagnostics
Recall class Class III
Status Terminated
Termination date Jun 18, 2008
FEI number 1000136573

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)