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Instrumentation Laboratory Co.

54 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 recall (Z-0895-2018)Instrumentation Laboratory Co.2018-03-03
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit con recall (Z-0736-2016)Instrumentation Laboratory Co.2016-02-01
HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensi recall (Z-0832-2015)Instrumentation Laboratory Co.2014-12-19
ACL TOP (Base), automated coagulation laboratory instrument. recall (Z-2060-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700, automated coagulation laboratory instrument. recall (Z-2061-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP CTS, automated coagulation laboratory instrument. recall (Z-2062-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700 LAS, automated coagulation laboratory instrument. recall (Z-2063-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 500 CTS, automated coagulation laboratory instrument. recall (Z-2064-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700 CTS, automated coagulation laboratory instrument. recall (Z-2065-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 300 CTS, automated coagulation laboratory instrument. recall (Z-2066-2014)Instrumentation Laboratory Co.2014-07-16
HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 recall (Z-0514-2014)Instrumentation Laboratory Co.2013-12-16
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 recall (Z-0515-2014)Instrumentation Laboratory Co.2013-12-16
HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 recall (Z-0516-2014)Instrumentation Laboratory Co.2013-12-16
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed recall (Z-2244-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed spe recall (Z-2245-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed spe recall (Z-2246-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed recall (Z-2247-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed recall (Z-2248-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random recall (Z-2249-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed recall (Z-2250-2013)Instrumentation Laboratory Co.2013-09-18
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the recall (Z-1784-2013)Instrumentation Laboratory Co.2013-07-22
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully auto recall (Z-2387-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automat recall (Z-2388-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automat recall (Z-2389-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully aut recall (Z-2390-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully aut recall (Z-2391-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully aut recall (Z-2392-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Numbe recall (Z-1519-2012)Instrumentation Laboratory Co.2012-05-10
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox 75 test iQM Part Numb recall (Z-2803-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox 75 test iQM Part recall (Z-2804-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/CO-Ox/tBili 75 test iQM Par recall (Z-2805-2011)Instrumentation Laboratory Co.2011-07-21
GEM PREMIER 4000 CARTRIDGE K+ REPORTING: GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili : 75 test i recall (Z-2806-2011)Instrumentation Laboratory Co.2011-07-21
Instrumentation Laboratory GEM Premier 3500 Blood Gas Analyzer PN 00026000000 The GEM Prem recall (Z-2673-2011)Instrumentation Laboratory Co.2011-06-27
Instrumentation Laboratory GEM Premier 4000 PN 00025000000 The GEM Premier 4000 is a porta recall (Z-2165-2011)Instrumentation Laboratory Co.2011-05-10
ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. recall (Z-0803-2011)Instrumentation Laboratory Co.2010-12-27
ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing. recall (Z-0804-2011)Instrumentation Laboratory Co.2010-12-27
ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing. recall (Z-0805-2011)Instrumentation Laboratory Co.2010-12-27
ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing. recall (Z-0806-2011)Instrumentation Laboratory Co.2010-12-27
ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing. recall (Z-0807-2011)Instrumentation Laboratory Co.2010-12-27
ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed sp recall (Z-0135-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed s recall (Z-0136-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed s recall (Z-0137-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed speci recall (Z-0138-2011)Instrumentation Laboratory Co.2010-10-25
Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. recall (Z-1127-2007)Instrumentation Laboratory Co.2007-08-07
GEM Premier 4000 Laboratory Analyzer recall (Z-0778-2007)Instrumentation Laboratory Co.2007-05-03
HemosIL RecombiPlasTin. Prothrombin Time Test. Each RecombiPlasTin kit consists of: Recomb recall (Z-1246-06)Instrumentation Laboratory Co.2006-07-18
Hemoliance RecombiPlasTin. Prothrombin Time Test. The product is available as a kit of 25 recall (Z-1247-06)Instrumentation Laboratory Co.2006-07-18
GEM PREMIER 3000 recall (Z-0378-06)Instrumentation Laboratory Co.2006-01-11
ACL Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPla recall (Z-0915-05)Instrumentation Laboratory Co.2005-06-21
ACL Futura Instrument Analyzer recall (Z-0736-04)Instrumentation Laboratory Co.2004-07-20
ACL Advance Instrument Analyzer recall (Z-0737-04)Instrumentation Laboratory Co.2004-07-20
Lactate Disposable Membrane Caps Product Number: 0018108400 recall (Z-0027-04)Instrumentation Laboratory Co.2003-10-15
GEM Premier 3000 Pak pH, pC02, pO2, Hct Sensor and Reagent Cartridge. Part No. 24330004 (3 recall (Z-0845-03)Instrumentation Laboratory Co.2003-05-20
GEM Premier 3000 Pak Sensor pH, pC02, pO2, Hct and Reagent Cartridge. Part No. 24345004 (4 recall (Z-0846-03)Instrumentation Laboratory Co.2003-05-20

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Every clearance here is in the API, with alerts when new ones post.