Recall Z-0198-2007 ยท JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Iris Sample Processing
StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502
| Date | Nov 21, 2006 (initiated Sep 29, 2006) |
| Status | Terminated |
| Reason | Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker. |
| Root cause | Other |
| Action | Iris telephoned customers on 9/29/06 and advised them of the recall of the rotor. New rotors were mailed Overnight Confirmed Delivery with instructions for replacement and return of the the old rotor. |
| Quantity | 94 units (Revised on 11/15/06 to 116 units) |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.