Retiro De Equipo (Recall) de Device Recall The Roche OMNI S Analyzer: cobas b 221, versions 5 and 6

Recall

70023

Class 2

Z-1041-2015

2014-12-18

2015-02-02

Terminated

United States

2017-02-06

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132123

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.

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 todd.siesky@roche.com.