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Roche Diagnostics Corp.

201 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. T recall (Z-2005-2009)Roche Diagnostics Corp.2009-09-16
Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. T recall (Z-2006-2009)Roche Diagnostics Corp.2009-09-16
Roche/Hitachi Preciset TDM I, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375790 19 recall (Z-2000-2009)Roche Diagnostics Corp.2009-09-10
Roche/Hitachi Preciset TDM II, Roche Diagnostics, Indianapolis, IN; Catalog No. 03375781 1 recall (Z-2001-2009)Roche Diagnostics Corp.2009-09-10
Roche ACCU-CHEK Softclix Lancing Device, Distributed by Roche Diagnostics, Indianapolis, I recall (Z-1590-2009)Roche Diagnostics Corp.2009-08-11
Roche ACCU-Chek Active Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 03184501001 inc recall (Z-1591-2009)Roche Diagnostics Corp.2009-08-11
Roche ACCU-Chek Voicemate Meter, Roche Diagnostics, Indianapolis, IN; REF 12030802001 incl recall (Z-1592-2009)Roche Diagnostics Corp.2009-08-11
Roche ACCU-Chek Aviva Meter Kit, Roche Diagnostics, Indianapolis, IN; REF 04893247001 incl recall (Z-1593-2009)Roche Diagnostics Corp.2009-08-11
Roche Coaguchex XS Systems for Patient Self-Testing, Roche Diagnostics, Indianapolis, IN; recall (Z-1594-2009)Roche Diagnostics Corp.2009-08-11
Roche ACCU-CHEK Compact Plus Meter Kit, Roche Diagnostics, Indianapolis, IN; REFS 03149137 recall (Z-1595-2009)Roche Diagnostics Corp.2009-08-11
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middlewar recall (Z-1393-2009)Roche Diagnostics Corp.2009-05-20
Roche cobas 6000 analyzer series (including cobas c 501 and cobas e 601 modules) Middlewar recall (Z-1394-2009)Roche Diagnostics Corp.2009-05-20
Roche MagNA Pure LC Workstation; Product Numbers: 12236931001, 12236931444, 12236931692 an recall (Z-1255-2009)Roche Diagnostics Corp.2009-05-18
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module, recall (Z-1065-2009)Roche Diagnostics Corp.2009-04-10
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module, recall (Z-1066-2009)Roche Diagnostics Corp.2009-04-10
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module, Roc recall (Z-1067-2009)Roche Diagnostics Corp.2009-04-10
Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module, Roc recall (Z-1068-2009)Roche Diagnostics Corp.2009-04-10
Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics recall (Z-1009-2009)Roche Diagnostics Corp.2009-03-24
Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc recall (Z-0542-2009)Roche Diagnostics Corp.2009-01-06
Roche/Hitachi Modular E Module immunoassay analyzer, Roche Diagnostics, Ind., IN; GMMI Nos recall (Z-0165-2009)Roche Diagnostics Corp.2008-10-22
Roche Diagnostics LDL_C, LDL- Cholesterol Plus 2nd generation, COBAS INTEGRA, cobas c syst recall (Z-0006-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics IRON2, Iron Gen. 2, COBAS INTEGRA, cobas c systems, Roche Diagnostics, I recall (Z-0007-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics CREP2, Creatinine Plus Ver. 2, COBAS INTEGRA, cobas c systems, Roche Dia recall (Z-0008-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c sys recall (Z-0009-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c syste recall (Z-0010-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics ALBT2, Tina-quant Albumin Gen. 2, COBAS INTEGRA, cobas c systems, Roche recall (Z-0011-2009)Roche Diagnostics Corp.2008-10-09
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianap recall (Z-0012-2009)Roche Diagnostics Corp.2008-10-09
Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical chemistry analy recall (Z-0866-2008)Roche Diagnostics Corp.2008-08-13
Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical chemistry analyz recall (Z-0867-2008)Roche Diagnostics Corp.2008-08-13
Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay analyzer; Catalo recall (Z-0868-2008)Roche Diagnostics Corp.2008-08-13
Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical chemistry analyzer; recall (Z-0869-2008)Roche Diagnostics Corp.2008-08-13
Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay analyzer; Catalog recall (Z-0870-2008)Roche Diagnostics Corp.2008-08-13
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Roche Diagnosti recall (Z-0576-2008)Roche Diagnostics Corp.2008-03-04
Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Cor recall (Z-0688-2008)Roche Diagnostics Corp.2008-02-08
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTE recall (Z-0377-2008)Roche Diagnostics Corp.2007-12-29
Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with Roche/Hitachi, CO recall (Z-0378-2008)Roche Diagnostics Corp.2007-12-29
Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with Roche/Hitachi, recall (Z-0379-2008)Roche Diagnostics Corp.2007-12-29
Roche Diagnostics LightCycler Capillaries (100uL) for use in conjunction with the LightCyc recall (Z-0459-2008)Roche Diagnostics Corp.2007-12-12
Roche Cortisol reagent for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys recall (Z-0977-2007)Roche Diagnostics Corp.2007-06-28
MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog # 03264793001. recall (Z-0956-2007)Roche Diagnostics Corp.2007-06-22
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 911,912, 917 and Modular P recall (Z-0917-2007)Roche Diagnostics Corp.2007-06-09
Roche Online TDM Tobramycin, for use on Roche/Hitachi analyzers 917 and Modular P; catalog recall (Z-0918-2007)Roche Diagnostics Corp.2007-06-09
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Ca recall (Z-0919-2007)Roche Diagnostics Corp.2007-06-09
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyze recall (Z-0920-2007)Roche Diagnostics Corp.2007-06-09
Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, recall (Z-0810-2007)Roche Diagnostics Corp.2007-05-16
Roche COBAS Integra DIG, Digoxin Reagent for use on the COBAS INTEGRA models 400, 400 plus recall (Z-0736-2007)Roche Diagnostics Corp.2007-04-13
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional us recall (Z-0737-2007)Roche Diagnostics Corp.2007-04-11
Roche IGGT COBAS INTEGRA Immunoglobulin G (Turbidimetric); Catalog no. 20766631322. in vit recall (Z-0356-2007)Roche Diagnostics Corp.2007-01-17
CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional us recall (Z-0227-2007)Roche Diagnostics Corp.2006-11-30
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Mater recall (Z-1550-06)Roche Diagnostics Corp.2006-09-29
Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717 recall (Z-1447-06)Roche Diagnostics Corp.2006-08-29
Accu-Chek Comfort Curve blood glucose test strips; (packaged in 10s, 50s, and/or 100s) U.S recall (Z-1377-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Advantage blood glucose test strips; U.S. Reference nos. (packaged in 50s and/or recall (Z-1378-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Advantage II blood glucose test strips; International Reference nos. 12030659001 recall (Z-1379-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Sensor Comfort blood glucose test strips; International Reference nos. 032619561 recall (Z-1380-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Sensor Comfort Pro blood glucose test strips; International Reference nos. 03758 recall (Z-1381-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Advantage Plus blood glucose test strips; International Reference no. 0473510200 recall (Z-1382-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Advantage Pro blood glucose test strips; International Reference no. 04534972001 recall (Z-1383-06)Roche Diagnostics Corp.2006-08-11
Accu-Chek Inform blood glucose test strips; International Reference nos. 04535057001, 0464 recall (Z-1384-06)Roche Diagnostics Corp.2006-08-11
Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Materi recall (Z-1385-06)Roche Diagnostics Corp.2006-08-09
ACCU-CHEK Advantage Blood Glucose Meter/ Blood Glucose Monitoring System; Cat. no. 870. Re recall (Z-1354-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Complete Diabetes Monitoring Kit, Cat. No. 860. Ref. no. 080086000 wit recall (Z-1355-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter recall (Z-1356-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter recall (Z-1357-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both w recall (Z-1358-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Comfort Curve. Cat. No. 3149030; Ref. number 0314903001 with meter model number recall (Z-1359-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Managed Care Kit) 100- value memory with time and date, Not for Retai recall (Z-1360-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Conversion Kit),Cat. no. 3000338; Ref no. 03000338001 with meter mode recall (Z-1361-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage (Consignment kit), Cat. no. 3000320; catalog no. 03000320001 with mete recall (Z-1362-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Complete diabetes monitoring kit/ care kit/ insulin pump therapy kit, Cat. no 51 recall (Z-1363-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Complete blood glucose monitor, Ref. no. 516; Catalog nos. 03266770001 and 03871 recall (Z-1364-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK HQ for Blood Glucose Monitoring and Automated Data Management and Communication; recall (Z-1365-06)Roche Diagnostics Corp.2006-08-05
AccuData GTS Plus for Blood Glucose Monitoring and Automated Data Management including GTS recall (Z-1366-06)Roche Diagnostics Corp.2006-08-05
AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, recall (Z-1367-06)Roche Diagnostics Corp.2006-08-05
GTS Advantage Meter. Cat. no. 424. Ref. no. 03144780001 with meter model no. 777. recall (Z-1368-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 recall (Z-1369-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - English languag recall (Z-1370-06)Roche Diagnostics Corp.2006-08-05
ACCU-CHEK Voicemate System, Advantage Blood Glucose Meter and Voice Unit - Spanish languag recall (Z-1371-06)Roche Diagnostics Corp.2006-08-05
Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose i recall (Z-1372-06)Roche Diagnostics Corp.2006-08-05
Roche MagNA Pure LC Instrument Kit; Catalog no. 12236931001. An automated, general purpose recall (Z-1373-06)Roche Diagnostics Corp.2006-08-05
Roche MagNA Pure LC Instrument; Catalog nos. 12236931444, 12236931692 ( Refurbished) and 1 recall (Z-1374-06)Roche Diagnostics Corp.2006-08-05
Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717 recall (Z-1352-06)Roche Diagnostics Corp.2006-08-03
Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System; in vitro diagnostic; recall (Z-1176-06)Roche Diagnostics Corp.2006-06-27
Roche/Hitachi Glucose Hexokinase Reagent for use on the Hitachi Modular System; Catalog # recall (Z-0899-06)Roche Diagnostics Corp.2006-05-25
Roche MagNA Pure LC System. An automated, general purpose instrument for isolation and pur recall (Z-0774-06)Roche Diagnostics Corp.2006-04-19
Roche MagNA Pure LC DNA Isolation Kit - Large Volume; Catalog number 03310515001. recall (Z-0775-06)Roche Diagnostics Corp.2006-04-19
Roche MagNA Pure LC Total Nucleic Acid Isolation Kit - Large Volume; Catalog number 032647 recall (Z-0776-06)Roche Diagnostics Corp.2006-04-19
Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373 recall (Z-0566-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Advantage blood glucose test strips; Reference numbers 03144917001, 03144704001, recall (Z-0567-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Advantage II blood glucose test strips; Reference numbers 12030659001, 120306670 recall (Z-0568-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Advantage Plus blood glucose test strips; Reference number 04735102001 (All sold recall (Z-0569-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Advantage Pro blood glucose test strips; Reference number 04534972001 (All sold recall (Z-0570-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Sensor Comfort blood glucose test strips; Reference numbers 03261956170, 0326196 recall (Z-0571-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Sensor Comfort Pro blood glucose test strips; Reference numbers 0375877001, 0336 recall (Z-0572-06)Roche Diagnostics Corp.2006-02-28
Accu-Chek Inform blood glucose test strips; Reference numbers 04535057001, 04647696001 and recall (Z-0573-06)Roche Diagnostics Corp.2006-02-28
Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216. recall (Z-0574-06)Roche Diagnostics Corp.2006-02-28
Roche brand Elecsys Troponin T; catalog number 2017644. recall (Z-0512-06)Roche Diagnostics Corp.2006-02-09
Roche brand Accu-Chek Aviva Care Kit; Catalog number 04528280001. (Distributed within the recall (Z-0417-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Meter Only Kit; Catalog number 04532279001. (Distributed withi recall (Z-0418-06)Roche Diagnostics Corp.2006-01-24
Roche brand Accu-Chek Aviva Bonus Pack; Catalog number 04528247001. (Distributed within th recall (Z-0419-06)Roche Diagnostics Corp.2006-01-24
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