CKDClass I

Hydrazone Colorimetry, Alt/sgpt

Clinical Chemistry · 21 CFR 862.1030

MDR events2All time

Recalls2All time

Registered firms8Currently listed

510(k) clearances11All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Malfunction2

Most-reported manufacturers

Roche Diagnostics2

Recalls

2 recall events for this product code

Alere San Diego, Inc.
TerminatedApr 17, 2013
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788.
The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST cassette, and it has the potential for humidity changes to impact results for certain analytes on the Alere Cholestech LDX System.
Z-1139-2013 · View FDA record ↗
Roche Diagnostics Corp.
TerminatedJul 31, 2004
Roche brand Reflotron GOT (AST), 30 test strips; catalog # 745120.
Coating defect may result is falsely decreased patient and/or control results.
Z-1302-04 · View FDA record ↗

Registered firms

8 firms currently registered for this product code

510(k) clearances

11 clearances for this product code