Cobas B 221 <4> System
Catalogue number 3337138001, listed by Roche Diagnostics Gmbh, Germany, under Electrode, Ion Specific, Potassium. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-20 |
| Record revised | 2025-10-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3337138001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Potassium electrode | Roche Diagnostics Gmbh | 4 |
| Potassium Electrode | Diamond Diagnostics Inc. | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Architect | Abbott Laboratories | 3 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| I.S.E. K | Randox Laboratories Limited | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Potassium Electrode | Medica Corp. | 2 |
| Na/K Solution Pack | Medica Corp. | 2 |
| Selectra | VitalScientific B.V. | 2 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253491 | 2026-02-12 |
| K060373 | 2006-03-13 |
| K032311 | 2003-10-17 |
| K013373 | 2001-11-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Roche Diagnostics Gmbh | UDI-DI | 2018-02-22 | Class II | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | 1026 total products | 2019-11-15 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-02-22 | Class II | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | 1026 total products | 2019-11-15 |
| 2018-02-22 | Class II | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | 1026 total products | 2019-11-15 |
| 2018-02-22 | Class II | Software design | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. | 1026 total products | 2019-11-15 |
| 2006-07-21 | Not classified | Other | Expired product (dated 2006.06) was shipped as replacement for recalled product. | 137 electrodes | 2006-11-01 |
| 2006-07-14 | Not classified | Other | A design change in the electrodes will result in incorrect potassium level results. | 1970 | 2007-12-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.