FDA Medical Device Recalls (openFDA)
Thermo Fisher Scientific: ThermoFisher Scientific Microm STP 420D automated tissue processor.
- Recall number
- Z-1320-2010
- Recalling firm
- Thermo Fisher Scientific
- Product
- ThermoFisher Scientific Microm STP 420D automated tissue processor.
- Status
- Terminated
- Initiated
- 2009-06-03
- Posted
- 2010-04-12
- Terminated
- 2011-06-29
- Reason
- 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.
- 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
- 16
- Distribution
- Hawaii, Kentucky, Louisiana, Michigan, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and West Virginia.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IEO
- Firm FEI
- 3006339565
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28