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 der
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling 82 cobas b 123 Fluid Packs (Catalog 05169992001) distributed nationwide in Louisiana, South Carolina, California, Texas, Nebraska, Virginia, West Virginia, and Puerto Rico. The affected lot numbers are 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). The cobas b 123 is a fully automated point-of-care system used to measure pH and other blood parameters from whole blood samples.
A calibration issue with the PO2 (partial pressure of oxygen) parameter in these fluid packs can cause erroneously low PO2 results, particularly in blood samples with PO2 values below 50 mmHg. Quality control failures may occur but could go undetected because results can fall below expected mean values while still remaining within acceptable statistical limits. The recall record does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico. Quantity: 82 fluid packs Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.