Roche Diagnostics Operations, Inc. recalls cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC syst…

Recall date

July 14, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2446-2015

FDA classification

Class II

Brand / firm

Roche Diagnostics Operations, Inc.

Sold / distributed

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

Why it was recalled

Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused by a calibration issue with the PO2 parameter. This issue may not be detected since QC results can be below mean values, but still within 2 standard deviations (SD) limits. Potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.