Z-1041-2015Class II

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

Name: Z-1041-2015 Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-12-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-12-18 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer on 2014-12-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1041-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-18
Posted: 2015-02-02
Terminated: 2017-02-06
Recalling firm: Roche Diagnostics GmbH
Product: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Roche Diagnostics has confirmed an issue with the calibration and QC stability of MSS parameters for cobas b 221 <6> systems. Internal investigations identified the formation of white deposits in the fluidic system, especially in the SD cartridge tubing, as the cause for the premature failure of the MSS parameters. These white deposits can potentially affect the fluidic pathways of both the Standby solution and the calibration solutions Cal1 to Cal4 (from the S3 Fluid Pack) and may reduce the lifetime of metabolite sensor cartridges. The cause of the white deposit has been identified as a chemical component of the S3 Fluid Pack solutions, as well as environmental bacterial contamination. Since this issue involves the S3 Fluid Pack, only the cobas b 221 <6> system is impacted. This issue may have an effect on the calibration of Glucose and Lactate parameters, which may lead to patient results being affected, as calibration drifts may not be detected by calibration and QC procedures. Glucose and Lactate are the only parameters affected by this issue. As a result, Roche is implementing an interim corrective action to be performed on your systems on a regular basis by Roche Field Engineering Specialist (FESs). Read the Urgent Medical Device Correction (UMDC) in its entirety. " Continue to run and maintain your cobas b 221 <6> system as per the Instructions for Use. " Complete the attached fax form and fax it to 1-888-656-6385. " File this UMDC for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC. Public Contact is Todd Siesky, at [email protected].
Quantity in commerce: 103
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1041-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1041-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-11	2015-02-02

Product code CGA

K032311Class IIRoche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. / cleared 2003-10-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)