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U.S. Department of Health and Human Services

Class 2 Device Recall Cobas b 123 POC system

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  Class 2 Device Recall Cobas b 123 POC system see related information
Date Initiated by Firm September 03, 2015
Date Posted January 23, 2017
Recall Status1 Terminated 3 on June 05, 2017
Recall Number Z-1077-2017
Recall Event ID 75709
510(K)Number K111188  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product Cobas b 123 POC system
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, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option
Code Information Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074  2274  2550  2302  2304  2309  1253  2420  2337  2147  2389  2418  2425  1749  2462  2338  2339  1850  2328  2500  1374  2301  1349  2400  2344  2350  1860  1941  2006  2128  
Recalling Firm/
Roche Diagnostics Operations, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
For Additional Information Contact
Manufacturer Reason
for Recall
under specific settings, an issue may occur during simultaneous Sensor Cartridge and Fluid Pack change on the cobas b 123 <2> POC system and cobas b 123 <4> POC system. The issue occurs when the software function [AutoQC as follow-up] is configured to run all three levels of AutoQC only after a Fluid Pack change, but not after a Sensor Cartridge change. When both are changed simultaneously, starting with the Sensor Cartridge and followed by the Fluid Pack, the analyzer carries out only the follow-up actions associated with the Sensor Cartridge change after completing the change workflow. As a result, no follow-up AutoQC is performed and the three expected AutoQC measurements for the Fluid Pack change are not carried out. Without running quality control, there is a remote possibility that system issues would not be detected and wrong results would not be excluded on all parameters: pH, PO2, PCO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, SO2, O2Hb, COHb, MetHb, HHb, and Bili.
FDA Determined
Cause 2
Software design
Action Roche issued an Analyzer Bulletin on September 3, 2015, to all affected Consignees. The recall notifications included a description of the reason for the recall, affected product, and consignee responsibilities; the notification did not include instructions for responding to the notification. Actions Required " Follow the workaround outlined in this Analyzer Bulletin to avoid the described issue. " File this Analyzer Bulletin for future reference. Questions Please contact the Roche Support Network Customer Support Center at 1-800-526-2272 if you have questions about the information contained in this Analyzer Bulletin.
Quantity in Commerce 30
Distribution Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = Roche Diagnostics