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Terminated

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.

K023857PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794Bio-Rad · 2003-05-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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