Cobas 6000 Core Unit
Catalogue number 07354436001, listed by Roche Diagnostics Gmbh, Germany, under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
1catalogue number
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Beijing Hotgen Biotech Co., Ltd. | Beijing | Beijing | Manufacturer | 13 |
| Yantai Addcare Bio-Tech Co., Ltd. | Yantai | Shandong | Contract manufacturer | 8 |
| Shenzhen NEW Industries Biomedical Engineering Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 4 |
| Shanghai Kehua Laboratory System Co., Ltd. | Shanghai | Shanghai | Manufacturer | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JJE |
| Device type | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K060373 |
| Record published | 2015-06-19 |
| Record revised | 2022-09-16 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07354436001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alinity | Abbott Medical | 283 |
| Architect | Abbott Laboratories | 115 |
| Alinity | Abbott Laboratories | 18 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 15 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 14 |
| Architect | Abbott Ireland Diagnostics | 8 |
| AU | Beckman Coulter, Inc. | 7 |
| Alinity | Abbott Ireland Diagnostics | 6 |
| DxC AU | Beckman Coulter, Inc. | 6 |
| Chemiluminescence Immunoassay Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 6 |
| Automated Chemiluminescent Enzyme Immunoassay Analyzer AIA-CL300 | Tosoh Corp. | 5 |
| Pictus 500 Clinical chemistry analyzer | Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag | 4 |
Showing 12 of 336. All products under Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Roche Diagnostics Operations | 510(k) number | 2019-07-18 | Class II | Device Design | Quality issue with high pressure solenoid valves may cause inaccurate results. | 1 unit | 2020-06-15 |
| Roche Diagnostics Gmbh | 510(k) number | 2017-12-18 | Class II | Labeling False and Misleading | Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 sample tubes without tube adapters. | 2019-04-09 | |
| Roche Diagnostics Gmbh | 510(k) number | 2017-07-18 | Class II | Device Design | A warning is being added to the cobas 6000 MODULAR Series System – c501 and the cobas 8000 MODULAR Analyzer Series – c502 Operator Manuals to prevent operator injury during maintenance. | 3433 | 2018-07-13 |
| Roche Diagnostics Gmbh | 510(k) number | 2017-06-29 | Class II | Software design | Roche has confirmed that a possible sample mismatch issue may occur on the MODULAR ANALYTICS E 170 module, cobas e 601 analyzer, or cobas e 602 analyzer due to a software limitation. | 2517 | 2020-01-24 |
| Roche Diagnostics Gmbh | 510(k) number | 2017-03-21 | Class II | Component change control | Due to a design change in 2015, corrosion on the sample probe electrical contacts can occur and lead to a disturbance of the sample liquid level detection (LLD). When disturbance of the sample liquid level detection (LLD) occurs, the affect | 3946 | 2017-10-02 |
| Roche Diagnostics Operations | 510(k) number | 2016-07-15 | Class II | Device Design | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. | 9014 in total | 2017-06-05 |
| Roche Diagnostics Operations | 510(k) number | 2014-05-21 | Class II | Labeling design | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. | 1147 | 2015-06-04 |
| Roche Diagnostics Operations | 510(k) number | 2014-05-21 | Class II | Labeling design | Under certain conditions loose ProCell/CleanCell aspiration tube filters may cause: consecutive discrepant results; sipper alarm; foam on reservoirs and system reagent alarms. | 149 | 2015-06-04 |
Recalls
10 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 |
|---|---|---|---|---|---|
| 2019-03-15 | Class II | Device Design | The firm has confirmed complaints regarding signal drops on the cobas e 801 module after a ProCell II M bottle changeover, which may lead to incorrect medical decisions with respect to diagnostics and patient treatment. | 149 | 2020-04-23 |
| 2018-12-14 | Class II | Device Design | COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over | 656 units | 2020-09-04 |
| 2018-12-14 | Class II | Device Design | COBAS INTEGRA 400 plus and cobas c 111 analyzers Additional Extra Wash Cycle Configurations and/or Batch Mode Needed for Specific Tests Due to Carry-over | 137 units | 2020-09-04 |
| 2018-04-03 | Class II | Process design | The syringe plunger on the device may be mounted in a tilted position, which applies mechanical stress to the plunger. In the worst case scenario, the plunger may crack leading to impaired syringe function. | 35 | 2019-11-21 |
| 2017-12-18 | Class II | Labeling False and Misleading | Complaints have been received concerning questionable results on analyzers due to customers utilizing 13 mm sample tubes without tube adapters. | 2019-04-09 | |
| 2017-12-18 | Class II | Labeling False and Misleading | Complaints have been received concerning questionable results on analyzers due to customers utilizing sample 13 mm tubes without tube adapters. | 2019-04-09 | |
| 2017-07-28 | Class II | Device Design | A software failure may incorrectly set the system settings to “default” settings, creating a risk of incorrect results. | 399 | 2020-06-10 |
| 2017-07-18 | Class II | Device Design | A warning is being added to the cobas 6000 analyzer and the cobas 8000 modular analyzer series Operators Manual to prevent operator injury during maintenance. | 245 | 2018-07-13 |
| 2017-07-05 | Class II | Software design | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch. | 255 instruments | 2019-04-30 |
| 2017-07-05 | Class II | Software design | A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch. | 923 instruments | 2019-04-30 |
| 2008-11-17 | Not classified | Nonconforming Material/Component | Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty val | 66 | 2009-12-08 |
| 2008-11-12 | Not classified | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. | 22 systems in all | 2009-09-22 |
| 2008-11-12 | Not classified | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. | 22 systems in all | 2009-09-22 |
| 2008-11-12 | Not classified | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. | 22 systems in all | 2009-09-22 |
| 2008-11-12 | Not classified | Software change control | If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results. | 22 systems in all | 2009-09-22 |
| 2008-06-24 | Not classified | Other | A software bug may result in pipetting from an incorrect reagent pack and/or assigning calibration curve parameters incorrectly. | 2009-10-22 | |
| 2008-03-21 | Not classified | Process change control | Possible mismatch between patient and result. | 11 of all models | 2009-11-18 |
| 2008-03-21 | Not classified | Process change control | Possible mismatch between patient and result. | 11 of all models | 2009-11-18 |
| 2008-03-21 | Not classified | Process change control | Possible mismatch between patient and result. | 11 of all models | 2009-11-18 |
| 2008-03-21 | Not classified | Process change control | Possible mismatch between patient and result. | 11 of all models. | 2009-11-18 |
| 2008-03-21 | Not classified | Process change control | Possible mismatch between patient and result. | 11 of all models | 2009-11-18 |
| 2004-08-06 | Not classified | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. | 2006-06-26 | |
| 2004-08-06 | Not classified | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. | 2006-06-26 | |
| 2004-08-06 | Not classified | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results if the analyzer is in operation and a channel has been masked or not requested over a period of time. | 254 | 2006-06-26 |
| 2004-08-06 | Not classified | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. | 138 | 2006-06-26 |
| 2004-08-06 | Not classified | Other | A software defect will allow the reporting out of believable, but clinically significant, erroneous results under certain conditions. | 2006-06-26 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-29 | Not classified | Other | The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments. | 2004-02-20 | |
| 2003-12-15 | Not classified | Other | If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume. | 2004-08-02 |
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.