FDA Device Intelligence
Home › Siemens Healthcare Diagnostics Products GmbH › N Antiserum to Human a1-Antitrypsin

N Antiserum to Human a1-Antitrypsin

Siemens Healthcare Diagnostics Products GmbH · Model 10446312 · UDI-DI 00842768009938

DEM
1
510(k) clearances
4
Adverse events
1
Recalls
23
Facilities

Description

Quantitative determination of a1-antitrypsin in human serum and plasma on BN Systems

Recalls

DateFirmReason
2017-08-23The Binding Site Group, Ltd.The high control for the kit is recovering low and may be out of range for assigned values.

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.