Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole bloo...
FDA Device Recall #Z-1077-2017 — Class II — September 3, 2015
Recall Summary
| Recall Number | Z-1077-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 3, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Diagnostics Operations, Inc. |
| Location | Indianapolis, IN |
| Product Type | Devices |
| Quantity | 30 |
Product Description
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
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.
Distribution Pattern
Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV
Lot / 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
Other Recalls from Roche Diagnostics Operations, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1476-2026 | Class II | cobas pro integrated solutions with cobas c 503... | Jan 20, 2026 |
| Z-1009-2026 | Class II | The Elecsys Anti-TSHR immunoassay is a three-st... | Nov 21, 2025 |
| Z-0489-2025 | Class II | cobas HCYS, Homocysteine Enzymatic Assay, Mater... | Oct 17, 2024 |
| Z-3187-2024 | Class II | Creatine Kinase (CK) used on cobas c 311/501/50... | Aug 15, 2024 |
| Z-0352-2024 | Class II | Tina-quant D-Dimer Test System, Fibrinogen/Fibr... | Oct 3, 2023 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.