Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)
FDA Recall Z-0199-2007 · Posted 2006-11-21
Recalling FirmDako Colorado, Inc.
Recall StatusTerminated
Product CodeKPA
Date Initiated2006-10-02
Date Terminated2007-02-01
Product Quantity11 units
Reason for Recall
Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
Firm Action
Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako.
Root Cause
Other
Distribution Pattern
Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.