Roche Cobas b 221 Blood Gas Analyzer Recalled for Measurement Bias
Roche Diagnostics is recalling 103 Cobas b 221 analyzers because bacterial contamination causes inaccurate glucose and lactate readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a defect that leads to inaccurate diagnostic results (glucose and lactate bias), which poses a risk of harm through misdiagnosis or treatment errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 103 units of the Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer. The recall covers units distributed nationwide in the United States.
The recall is due to a chemical component in the F3 Fluid pack and environmental bacterial contamination. These factors cause a positive bias in measurements, resulting in glucose readings up to 39% higher and lactate readings up to 30% higher at specific concentrations. Urea readings are not affected by this issue.
Healthcare facilities and laboratories should stop using the affected analyzers and contact Roche Diagnostics for instructions on returning or replacing the equipment.
The recalled product
- Product
- Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 103
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (17)
- 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.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · inaccurate measurement
See all →- ModerateFujifilm Synapse PACS Software Recalled for Inaccurate Ruler Measurements
FDA (Devices) · 2026-09-02
- HighMerge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
FDA (Devices) · 2026-09-02
- High3mensio Workstation Software Recalled Due to Inaccurate Cardiovascular Measurements
FDA (Devices) · 2026-07-29
- HighOral thermometer probes recalled after being programmed with rectal configuration
FDA (Devices) · 2025-10-29
- HighUltrasound systems recalled over inaccurate liver steatosis measurement values
FDA (Devices) · 2025-10-22