FDA Device Intelligence
Home › BIO-RAD › Platelia

Platelia

BIO-RAD · Model 12014064 · UDI-DI 03610522189380

NOM
1
510(k) clearances
1
Adverse events
2
Recalls
3
Facilities

Description

Platelia Aspergillus Ag

Recalls

DateFirmReason
2005-01-25Bio Rad Laboratories, Inc.New instructions to recommend against using samples with visibly high level of blood.
2003-11-06Bio Rad Laboratories, Inc.Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.