Roche Diagnostics Operations, Inc.: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

Is my product affected?

Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer

• UPC 03337154692

Check against the official notice below — it lists the full affected range.

What happened

Roche Diagnostics Operations, Inc. is recalling the Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer due to chemical components in the F3 Fluid pack and environmental bacterial contamination. These issues cause glucose measurements to read up to 39% higher than actual values at 4.1 mmol/l and lactate measurements to read up to 30% higher than actual values at 4.12 mmol/l. Urea readings are not affected by this issue. The recall affects 103 units distributed nationwide across the United States.

The recall applies to specific model and catalog numbers including the cobas b 221 (versions 5 and 6) and catalog number 03337154692. The affected analyzers are used to measure multiple blood components including potassium, calcium, sodium, chloride, blood gases, hemoglobin, hematocrit, oxygen saturation, and other related markers. The source document does not specify what action affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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: US Nationwide distribution. Quantity: 103 Lot/code info: 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

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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