Z-0199-2007

Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER...

Name: Z-0199-2007 Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER...
Creator: Dako Colorado, Inc.
Published: 2006-10-02
License: https://open.fda.gov/license/

Dako Colorado, Inc. / initiated 2006-10-02 / Terminated

FDA source

Dako Colorado, Inc. began a recall of Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431) on 2006-10-02. The reason FDA records is "Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0199-2007
Status: Terminated
Initiated: 2006-10-02
Posted: 2006-11-21
Terminated: 2007-02-01
Recalling firm: Dako Colorado, Inc.
Product: Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc. (Catalog No. (ER 00130,00331,00230,00431)
Product code: KPA Slide Stainer, Automated
Reason for recall: Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
FDA root cause: Other
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.
Quantity in commerce: 11 units
Distribution: Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain.
Product codes and lots: Serial numbers: ER103, ER105, ER106, ER107, ER108, ER110, ER111, ER113, ER115, ER117, ER118.

Product code KPA

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)