Z-1320-2010

ThermoFisher Scientific Microm STP 420D automated tissue processor

Name: Z-1320-2010 ThermoFisher Scientific Microm STP 420D automated tissue processor
Creator: Thermo Fisher Scientific
Published: 2009-06-03
License: https://open.fda.gov/license/

Thermo Fisher Scientific Oy / initiated 2009-06-03 / Terminated

FDA source

Thermo Fisher Scientific began a recall of ThermoFisher Scientific Microm STP 420D automated tissue processor on 2009-06-03. The reason FDA records is "The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1320-2010
Status: Terminated
Initiated: 2009-06-03
Posted: 2010-04-12
Terminated: 2011-06-29
Recalling firm: Thermo Fisher Scientific Oy
Product: ThermoFisher Scientific Microm STP 420D automated tissue processor.
Product code: IEO Processor, Tissue, Automated
Reason for recall: The firm has received complaints regarding specimen integrity (higher rate of specimen fragmentation) as well as complaints that the chamber may stop rotating prematurely, resulting in sample deterioration.
FDA root cause: Other
Action: Consignees were notified of the problem by letter, on or about 6/3/09, updating the instructions for use. The units were subsequently upgraded on or before 9/8/09. For additional questions and information, please contact ThermoFisher's Technical Support department , Subject: PT Module Advisory Notice.
Quantity in commerce: 16
Distribution: Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
Product codes and lots: All units.

Product code IEO

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)