StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes.
This recall has been terminated (originally issued March 4, 2010).
- Recall Initiated
- January 27, 2010
- Posted
- March 4, 2010
- Terminated
- November 13, 2019
- Recall Number
- Z-0807-2010
- Quantity
- 1510 units
- Firm Location
- Westwood, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
Distribution
Worldwide Distribution -- USA, CANADA, AUSTRALIA, JORDAN, UK, BELGIUM, FRANCE, CZECH, RUSSIA, KUWAIT', NORWAY, GREECE, TURKEY, DENMARK, FINLAND, SEOUL, KOREA, and HONG KONG.
Lot / Code Info
Serial Numbers: 00100 through 001679.
Root Cause
Device Design
Action Taken
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.