Recall Z-1151-04 ยท LEH Radioimmunoassay, Vancomycin
Beckman Coulter Inc
Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.
| Date | Jul 23, 2004 (initiated Apr 1, 2003) |
| Status | Terminated |
| Reason | The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three). |
| Root cause | Other |
| Quantity | 9730 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013235 | MODIFICATION TO SYNCHRON CONTROL Beckman Coulter, Inc., Oct 16, 2001 |