Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
FDA Recall #Z-1041-2015 — Class II — December 18, 2014
Product Description
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Reason for Recall
Chemical component of the F3 Fluid pack and environmental bacterial contamination causes a positive bias up to 39% at 4.1 mmol/l for the glucose measurement and 30% at 4.12 mmol/l for lactate. Urea readings are unaffected.
Recalling Firm
Roche Diagnostics Operations, Inc. — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
103
Distribution
US Nationwide distribution.
Code Information
Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM CU Potassium - CEM, Calcium - JFP, Sodium - JGS, Chloride - CGZ, Blood Gases (PCO2, PO2) and pH - CHL, Hemoglobin -GKR, Hematocrit - GKF, Oxygen saturation, Carboxyhemoglobin - GHS, Oxyhemoglobin - GGZ, Methemoglobin - KHG, Deoxyhemoglobin - GKA, Lactic Acid - KHP, Glucose- CGA, Urea Nitrogen - CDS.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated