FDA Medical Device Recalls (openFDA)
Bio Rad Laboratories, Inc.: Platelia Aspergillus EIA
- Recall number
- Z-0348-04
- Recalling firm
- Bio Rad Laboratories, Inc.
- Product
- Platelia Aspergillus EIA
- Status
- Terminated
- Initiated
- 2003-11-06
- Posted
- 2004-01-14
- Terminated
- 2004-01-27
- 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.
- Lot, serial or model codes
- Lot number: 3F0001 Exp. 2004-05-15
- 510(k) numbers
- ["K023857"]
- PMA numbers
- not on file
- Product code
- NOM
- Firm FEI
- 3008272466
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28