510(k) · Cleared
Recalled · Class II · 2015Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Cleared on May 14, 2012 as substantially equivalent to K032311 (Roche Diagnostics Corp., 2003) and 3 other predicates after a 383-day review. Its family tree reaches back 4 generations to 1994. It has been recalled 4 times.
- Decided
- May 14, 2012
- Review
- 383 days
- Class
- Class II
- Product code
- CHL
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 4 generations to K940918 (1994). 11 ancestors in all, the oldest K913133 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK940918 I-Stat 200 Portable Clinical AnalyzerI-Stat Corp. · 1994 · Recalled
- 3 generations backK990092 Avl Omni Modular AnalyzerAvl Scientific Corp. · 1999 · Recalled
- 2 generations backK013373 Omni C AnalyzerRoche Diagnostics Corp. · 2001 · Recalled
- 1 generation backK032311 Roche Diagnostics Omni S AnalyzerRoche Diagnostics Corp. · 2003 · Recalled
- This deviceK111188 Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B…Roche Diagnostics · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K940918 | I-Stat 200 Portable Clinical Analyzer | I-Stat Corp. | 1994 | 19 |
| −3 | K990092 | Avl Omni Modular Analyzer | Avl Scientific Corp. | 1999 | 4 |
| −2 | K013373 | Omni C Analyzer | Roche Diagnostics Corp. | 2001 | 1 |
| −1 | K032311 | Roche Diagnostics Omni S Analyzer | Roche Diagnostics Corp. | 2003 | 9 |
| 0 (this device) | K111188 | Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc… | Roche Diagnostics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CHL device
- #1 K252207 ABL90 FLEX PLUS System, safeCLINITUBESscore 14.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032311 | Roche Diagnostics Omni S AnalyzerSummary page 7…intended for similar use. We claim equivalency to the following currently marketed products: * cobas b 221 (OMNI S) Blood Gas System-K03231 1 *Hitachi 902 Analyzer (Glucose and Lactate)-K92 1661 *cobas c 501 Analyzer (Glucose and.… | 2003 |
| * | K921661 | Boehringer Mannheim/ Hitachi 911 AnalyzerSummary page 7…llowing currently marketed products: * cobas b 221 (OMNI S) Blood Gas System-K03231 1 *Hitachi 902 Analyzer (Glucose and Lactate)-K92 1661 *cobas c 501 Analyzer (Glucose and. Lactate)-K060373/AO1 *COMBITROL PLUS B /AUTOTROL PLUS… | 1992 |
| * | K060373 | Cobas 6000 Series SystemSummary page 7…NI S) Blood Gas System-K03231 1 *Hitachi 902 Analyzer (Glucose and Lactate)-K92 1661 *cobas c 501 Analyzer (Glucose and. Lactate)-K060373/AO1 *COMBITROL PLUS B /AUTOTROL PLUS B-K032453… | 2006 |
| * | K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte ControlSummary page 7…alyzer (Glucose and Lactate)-K92 1661 *cobas c 501 Analyzer (Glucose and. Lactate)-K060373/AO1 *COMBITROL PLUS B /AUTOTROL PLUS B-K032453 Continued on next page Confidential… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2015 | Class II | Z-1077-2017 | Software design | 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… |
| Jul 14, 2015 | Class II | Z-2446-2015 | Nonconforming Material/Component | 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… |
| Jul 14, 2015 | Class II | Z-2447-2015 | Nonconforming Material/Component | 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… |
| Nov 14, 2012 | Class II | Z-0522-2013 | Software design (manufacturing process) | It has been determined that cobas b 123 Fluid Pack COOX cuvettes for lot numbers 21426121 and 21426171, exhibit a significant increase in the out-of-box failure rate caused by a change in the thickness in the cuvette layer. Internal… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 4.7 years on median.
- 8 of the 11 ancestors have a recall of any class.
How does its category compare?
All CHL devicesCHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · CHL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHL
267in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHL
13so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHL
210in 2025
MAUDE reports naming product code CHL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 6 | 16 |
| 2008 | 1 | — | 5 | 40 |
| 2009 | 0 | — | 6 | 74 |
| 2010 | 1 | — | 7 | 20 |
| 2011 | 4 | 108 | 1 | 50 |
| 2012 | 4 | 65 | 9 | 64 |
| 2013 | 5 | 152 | 1 | 62 |
| 2014 | 3 | 68 | 1 | 93 |
| 2015 | 4 | 155 | 3 | 55 |
| 2016 | 3 | 306 | 1 | 118 |
| 2017 | 1 | — | 1 | 206 |
| 2018 | 1 | — | 3 | 174 |
| 2019 | 0 | — | 0 | 141 |
| 2020 | 4 | 100 | 2 | 117 |
| 2021 | 2 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 138 |
| 2023 | 5 | 267 | 4 | 177 |
| 2024 | 1 | — | 9 | 196 |
| 2025 | 1 | — | 0 | 210 |
| 2026 | 1 | — | 13 | — |
What is it indicated for?
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na', K*, iCa2* (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2 Hb, HHb, COHb, MetHb), and oxygen saturation (SO 2) 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…
Read the full statement (562 words)
The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na', K*, iCa2* (ISE), hematocrit (Hct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2 Hb, HHb, COHb, MetHb), and oxygen saturation (SO 2) 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.
PH, P02 and PCO 2 : PH, P0 2 and PCO 2 measurements are used in the diagnosis and treatment of life-threatening acid-base disturbances.
Sodium (Na 4 ): sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic secretion, or other diseases involving electrolyte imbalance.
Potassium (K1 ): potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels.
Calcium (Ca 2"): calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Hematocrit (Het): hematocrit measurements are used to distinguish normal from abnormal states of whole blood, such as anemia and erythrocytosis (an increase in the number of red cells).
Glucose (Glu): glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemnia, and of pancreatic. islet cell carcinoma.,
Lactate (Lac): Lactate measurements are used to evaluate the acid-base status and are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood.)
Total Hemoglobin (tHb): total hemoglobin measurements are used to measure the hemoglobin content of whole blood for the detection of anemia.
O2Hb: oxyhemoglobin as a fraction of total hemoglobin.
COHb: carboxyhemoglobin measurements are used to determine the carboxyhemoglobin content of human blood as an aid in the diagnosis of carbon monoxide poisoning.
Meti-b: methemoglobin as a fraction of total hemoglobin.
HHb: reduced hemoglobin as a fraction of total hemoglobin.
SO 2 : oxygen saturation, more specifically the ratio between the concentration of oxyhemoglobin and oxyhemoglobin plus reduced hemoglobin.
The cobas b 123 AutoQC pack Tni-Level is a multi-analyte control intended for use as control material to monitor the measurement of PH, PCO2 , P0 2 , SO2 , Nat, K+, iCa2+, Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
The cobas b 123 AutoCVC Pack is a multi-analyte control, intended for use in calibration verification of the measuring range established by the cobas b 123 POC system for PH, PCO2 , P0 2 , SO2 , Nat, K+, iCa 2 +,Hct, tHb and Hb derivatives as well as glucose and lactate on cobas b 123 systems with an AutoQC module.
COMBITROL PLUS B is a multi-analyte control intended for use as control material to monitor the measurement of pH, PCO2 , P0 2 , SO 2, Nat; Kt., CE, iCa 2 +,Uct, ti-b and Hb derivatives as well as glucose, lactate, urea/BUN and bilirubin on Roche OMNI S or cobas b 221 analyzers with an oximeter module, and cobas b 123 analyzers (except urea/BUN, chloride, and bilirubin). COMBITROL PLUS B control material is not intended for use with analyzers from other manufacturers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111188
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026