Recall Z-0807-2010 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
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.
| Date | Mar 4, 2010 (initiated Jan 27, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.