FDA Medical Device Recalls (openFDA)
StatSpin, Inc., dba Iris Sample Processing: StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
- Recall number
- Z-0807-2010
- Recalling firm
- StatSpin, Inc., dba Iris Sample Processing
- Product
- StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
- Status
- Terminated
- Initiated
- 2010-01-27
- Posted
- 2010-03-04
- Terminated
- 2019-11-13
- Reason
- Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
- Root cause
- Device Design
- Action
- Iris Sample Processing notified distributors by an Urgent Device Recall letter advising of the recall and the defect. Users are to immediately quarantine the affected products and choose between the two options listed in regards to correcting the affected centrifuge. Customers may return the unit or an upgrade kit with instructions will be sent to upgrade the unit. Questions should be directed to Gail Magrath at 800-782-8774 ext. 6123.
- Quantity
- 1510 units
- Distribution
- Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.
- Lot, serial or model codes
- Serial Numbers: 00100 through 001679.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQC
- Firm FEI
- 1221015
- Firm city
- Westwood
- Firm state
- MA
- 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