Platelia Aspergillus EIA
FDA Recall Z-0348-04 · Posted 2004-01-14
Recalling FirmBio Rad Laboratories, Inc.
Recall StatusTerminated
Product CodeNOM
Date Initiated2003-11-06
Date Terminated2004-01-27
Product Quantity147 kits
Reason for Recall
Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
Firm Action
Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.
Root Cause
Other
Distribution Pattern
The firm distributed to hospitals and diagnostic laboratories nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.