Z-1077-2017Class II

Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro...

Name: Z-1077-2017 Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro...
Creator: Roche Diagnostics Operations, Inc.
Published: 2015-09-03
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2015-09-03 / Terminated / root cause: software

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2015-09-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1077-2017
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Posted: 2017-01-23
Terminated: 2017-06-05
Recalling firm: Roche Diagnostics GmbH
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
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1077-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1077-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23

Product code CHL

K111188Class IICobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus BRoche Diagnostics / cleared 2012-05-14

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)