StatSpin Express 4 Horizontal Centrifuge Model # M510. Intended Use: Rapid Separation of plasma and serum from primary g
FDA device recall Z-0807-2010 · posted 2010-03-04 · Terminated
Recall details
- Recalling firm
- StatSpin, Inc., dba Iris Sample Processing
- Reason for recall
- Centrifuge shield micro-switch failed due to damage, and the unit opened, ejecting pieces.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JQC
- Quantity affected
- 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.
- Date initiated
- 2010-01-27
- Date posted
- 2010-03-04
- Date terminated
- 2019-11-13
- Location
- Westwood, MA
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