Recall Z-0348-04 ยท NOM Antigen, Galactomannan, Aspergillus Spp.
Bio Rad Laboratories, Inc.
Platelia Aspergillus EIA
| Date | Jan 14, 2004 (initiated Nov 6, 2003) |
| Status | Terminated |
| Reason | Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan. |
| Root cause | Other |
| Action | Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003. |
| Quantity | 147 kits |
| Distribution | The firm distributed to hospitals and diagnostic laboratories nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023857 | PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 Bio-Rad, May 16, 2003 |