Recall Z-2169-2011 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
StatSpin, Inc., dba Iris Sample Processing
Statspin Express 4 Centrifuge Model Number: SSH4 Intended Use: Rapid Separation of plasma and serum from primary gel collection tubes
| Date | May 10, 2011 (initiated Aug 18, 2010) |
| Status | Terminated |
| Reason | Rotors may fail due to wire spokes breaking |
| Root cause | Device Design |
| Action | Iris notified customers by letter in August 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to install the new rotors and discard the older rotors with the wires. There was no need for customers to return the rotors, but the firm requested customers fax or e-mail the enclosed form to verify that they have installed the new rotors. For any questions customers should call 1-800-782-8774. |
| Quantity | 2090 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia Belgium, Czech Republic, Finland, France, Greece, Kuwait, Norway, Turkey,UK, and Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.