Enzyme Controls (assayed And Unassayed)
Clinical Chemistry · 21 CFR 862.1660
Recent MDR events
18 adverse event reports on file
- METER TRAX CONTROLFeb 23, 2011OtherBio-rad Laboratories2016706-2011-00001
- PERKINELMER NEONATAL GALT KITNov 12, 2010OtherPerkinelmer Wallac Oy8043909-2010-00001
- LIQUICHEK CARDIAC MARKERS PLUS CONTROL LTMar 31, 2009OtherBio-radd, Laboratories2016706-2009-00001
- POLYMEDCO SEDCHEK (ABNORMAL)Dec 13, 2007Other2016706-2007-00003
- VITROS CHEMISTRY PRODUCTS CKMB SLIDESNov 23, 2004MalfunctionOrtho-clinical Diagnostics9680658-2004-00308
- LIQUICHEK CARDIAC MARKERS CONTROL LTOct 5, 2004OtherBio-rad Laboratories2016706-2004-00002
- VITROS CHEMISTRY PRODUCTS CKMB SLIDESJun 8, 2004MalfunctionOrtho-clinical Diagnostics, Inc.1319809-2005-00118
- LIQUICHEK BLOOD GAS CONTROL CO-OXIMETERDec 23, 2003InjuryBio-rad Laboratories2016706-2003-00004
- LIQUICHECK IMMUNOASSAY PLUS CONTROLOct 6, 2003InjuryBio-rad Laboratories2016706-2003-00003
- LIQUICHEK URINALYSIS CONTROLJun 13, 2003OtherBio-rad Laboratories2016706-2003-00002
Event type breakdown
Recalls
2 recall events for this product code
- Abbott Point Of Care Inc.TerminatedNov 2, 2012
Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039)
Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials.
Z-0192-2013 · View FDA record ↗ - PerkinElmer LIfe Sciences IncTerminatedMay 29, 2003
Neonatal GALT Test Kit, 960 tests per box, packaged under the PerkinElmer Life Sciences Inc. label, catalog No. NG-1100.
The Control Cards are incorrectly labeled such that the normal 'N' and abnormal 'A' values are reversed.
Z-0898-03 · View FDA record ↗
Registered firms
20 firms currently registered for this product code
Abbott Laboratories
Lake Forest, IL, US
Astoria-pacific, Inc.
Clackamas, OR, US
Diazyme Laboratories, Inc.
POWAY, CA, US
Verichem Laboratories, Inc.
Providence, RI, US
Alere San Diego, Inc.
San Diego, CA, US
Shino-test Corporation
Sagamihara Kanagawa, JP
More Diagnostics Inc.
Los Osos, CA, US
Randox Laboratories Limited
CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB
Roche Diagnostics Gmbh
MANNHEIM Baden-Wurttemberg, DE
Wallac Oy
TURKU Varsinais-Suomi, FI
Biokit S.a.
LLISSA D AMUNT Barcelona, ES
Aalto Scientific Ltd.
Eatonton, GA, US
Bio-rad Laboratories Inc.
IRVINE, CA, US
Bio-rad Laboratories Inc.
Irvine, CA, US
Cliniqa Corporation
San Marcos, CA, US
Helena Laboratories, Corp.
BEAUMONT, TX, US
510(k) clearances
97 clearances for this product code
- Astoria-Pacific, Inc.Dec 14, 2009
K090940 · SPOTCHECK BLOOD SPOT CONTROL, ASSAYED
- Quantimetrix Corp.Oct 3, 2006
K062751 · MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
- Cliniqa CorporationMar 21, 2003
K030768 · CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
- Bayer Healthcare, LLCJan 24, 2003
K030102 · ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3
- Bio-RadMay 24, 2002
K021498 · LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
- Bio-RadSep 6, 2001
K012656 · LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648
- Quantimetrix Corp.Nov 23, 1999
K993723 · CARDIASURE CARDIAC MARKERS CONTROL
- Seracare TechnologyNov 16, 1999
K993715 · QUALITROL CARDIAC MARKER CONTROL, LEVELS, 1,2 AND 3