Device Recall Roche

Lots T10786 T13091, T15435, T15475, T14777, and W00389

Immunology and Microbiology Devices

3

No

Foreign Distributed.

cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. || Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.

T08661

Immunology and Microbiology Devices

3

No

Foreign

cobas¿ EGFR Mutation Test || epidermal growth factor receptor (EGFR) gene DNA assay

cobas b 123 Fluid Pack COOx Catalog 05169992001, lot numbers 21446113 (exp 8/8/2015), 21446123 (exp 8/18/2015), 21446153 ( exp 9/18/2015), 21446183 (exp 9/19/2015), and 21446203 (exp 10/01/2015)

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.

cobas b 123 Fluid Pack COOX REF 05169992001 200 || Product Usage: || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.

cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015)

Clinical Chemistry and Clinical Toxicology Devices

2

No

US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.

cobas b 123 Fluid Pack COOX REF 05170036001 400 || Product Usage: || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.

EGFR v2: 07248563190 cfDNA: 07247737190

Immunology and Microbiology Devices

3

No

Hungary

cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample || Preparation Hungarian Translation Instructions for Use