Recall of Device Recall Roche cobas b 123 POC system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Roche Diagnostics Operations, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Reason
    Low po2 results. qc failures of the po2 parameter, affecting primarily levels 1 and 2, caused by a calibration issue with the po2 parameter. this issue may not be detected since qc results can be below mean values, but still within 2 standard deviations (sd) limits. potential for erroneously low po2 results in patient samples, especially in blood samples with po2 values below 50 mmhg.
  • Action
    Roche sent an Urgent Medical Device Correction letter dated July 14, 2015 and the Fax Back form via UPS ground to the customers list. The letter identified the affected product, problem and actions to be taken. Consignees are instructed to discontinue use of affected Fluid Packs and discard them per local guidlines; and complete and return the enclosed faxback form and fax it to 1-888-943-5171 to receive replacement product for Fluid Packs from the affected lot. For questions contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272.


  • Model / Serial
    cobas b 123 Fluid Pack COOx Catalog 05169992001, lot numbers 21446113 (exp 8/8/2015), 21446123 (exp 8/18/2015), 21446153 ( exp 9/18/2015), 21446183 (exp 9/19/2015), and 21446203 (exp 10/01/2015)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Nationwide Distribution in the states of LA, SC, CA, TX, NE, VA and WV including: Puerto Rico.
  • Product Description
    cobas b 123 Fluid Pack COOX REF 05169992001 200 || Product Usage: || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials.
  • Manufacturer


  • Manufacturer Address
    Roche Diagnostics Operations, Inc., 9115 Hague Rd, Indianapolis IN 46256-1025
  • Manufacturer Parent Company (2017)
  • Source