COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B— 510(k) K111188

Clearance details

Applicant

Roche Diagnostics

Product code

Code CHL

Device class

Class 2

Regulation

21 CFR 862.1120

Advisory panel

Clinical Chemistry

Date received

2011-04-27

Decision date

2012-05-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Indianapolis, IN, US

• K252207 — ABL90 FLEX PLUS System, safeCLINITUBES2026-04-10
• K244014 — i-STAT CG4+ cartridge with the i-STAT 1 System2025-05-02
• K240998 — ABL90 FLEX PLUS System2024-12-13
• K230285 — i-STAT CG8+ cartridge with the i-STAT 1 System2023-10-27
• K221900 — Stat Profile Prime Plus Analyzer System2023-09-29

• K261686 — Elecsys Phospho-Tau (217P) Plasma2026-08-19
• K252323 — cobas pulse blood glucose monitoring system2026-06-12
• K252280 — Elecsys Anti-SARS-CoV-2 S2026-04-13
• K260046 — Elecsys Anti-HBc II2026-04-07
• K260048 — Elecsys Anti-HAV IgM2026-04-07

Death

20

Malfunction

999

Total

1,019

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• 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 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 optionClass II·Terminated·Roche Diagnostics Operations, Inc.·20150903
• Z-2446-2015 — 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.Class II·Terminated·Roche Diagnostics Operations, Inc.·20150714
• Z-2447-2015 — cobas b 123 Fluid Pack COOX REF 05170036001 400 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.Class II·Terminated·Roche Diagnostics Operations, Inc.·20150714
• Z-0522-2013 — Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COHB, 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.Class II·Terminated·Roche Diagnostics Operations, Inc.·20121114

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111188.