Recall Z-0574-06 ยท LFW Fluorescence Polarization Immunoassay, Tobramycin
Roche Diagnostics Corp.
Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
| Date | Feb 28, 2006 (initiated Feb 10, 2006) |
| Status | Terminated |
| Reason | May have tobramycin over-recovery at the trough level. |
| Root cause | Other |
| Action | Consignees were notified via phone and faxed recall letter on or about 2/10/06. |
| Quantity | 1806 kits |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K912143 | CEDIA(R) TOBRAMYCIN ASSAY Microgenics Corp., Jul 26, 1991 |