FDA Device recall Z-1041-2015
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer by Roche Diagnostics Operations, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1041-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-18 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Diagnostics Operations |
| Distribution | US |
Product
Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Reason
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.
Identifiers
| code_info | Model/Catalog/Part #: 1. cobas b221 <6>=Roche OMNI S6 SYSTEM; and 2. 03337154692 - cobas b 221<6>=Roche OMNI S6 SYSTEM…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1041-2015%22
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