Device Recall Roche cobas

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.

Not applicable

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution

cobas p 312 Pre-Analytical System || calculator/data processing module, for clinical use || Product Usage: || The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.

Not applicable

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution

cobas p 471 centrifuge unit || calculator/data processing module, for clinical use || Product Usage: || The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.

Not applicable

Clinical Chemistry and Clinical Toxicology Devices

1

No

US Nationwide Distribution

Roche COBAS INTEGRA 800 /800 CTS Analyzer || Analyzer, Chemistry (Photometric, Discrete for Clinical use || Product Usage: || The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.