Z-0348-04

Platelia Aspergillus EIA

Name: Z-0348-04 Platelia Aspergillus EIA
Creator: Bio Rad Laboratories, Inc.
Published: 2003-11-06
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2003-11-06 / Terminated

FDA source

Bio Rad Laboratories, Inc. began a recall of Platelia Aspergillus EIA on 2003-11-06. The reason FDA records is "Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0348-04
Status: Terminated
Initiated: 2003-11-06
Posted: 2004-01-14
Terminated: 2004-01-27
Recalling firm: Bio-Rad Laboratories Inc.
Product: Platelia Aspergillus EIA
Product code: NOM Antigen, Galactomannan, Aspergillus Spp.
Reason for recall: Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.
FDA root cause: Other
Action: Customers were sent a letter, Technical Bulletin and revised package insert on November 6, 2003.
Quantity in commerce: 147 kits
Distribution: The firm distributed to hospitals and diagnostic laboratories nationwide.
Product codes and lots: Lot number: 3F0001 Exp. 2004-05-15

Product code NOM

K023857Class IPlatelia Aspergillus Eia, Models 62793 and 62794Bio-Rad / cleared 2003-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)