Z-1041-2015 Class II Terminated
FDA device recall Z-1041-2015 was initiated by Roche Diagnostics Operations, Inc. on Dec 18, 2014 and is designated Class II. 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… The recall status is terminated (terminated Feb 6, 2017). Affected quantity: 103.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 11, 2015
- Initiation Date
- Dec 18, 2014
- Termination Date
- Feb 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 103
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.
Distribution Pattern
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1041-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026