Recall Z-1369-05 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Beckman Coulter Inc
Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
| Date | Aug 13, 2005 (initiated May 5, 2005) |
| Status | Terminated |
| Reason | Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures. |
| Root cause | Process change control |
| Action | Recall letters mailed 5/5/2005 request users monitor the temperature variances and evaluate for continued use in thier laboratory. |
| Quantity | 46 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.