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Catalogue number 10170280001, listed by Roche Diagnostics Gmbh, Germany, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
11recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10170280001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftLab | SCC Soft Computer | 64 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-04-04 | Class III | Nonconforming Material/Component | There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument. | 4 units | 2020-05-12 |
| 2019-04-04 | Class III | Nonconforming Material/Component | There is a potential for the tray input flap on the post analytical units to become loose, potentially detaching from the instrument. | 9 units | 2020-05-12 |
| 2019-02-04 | Class II | Software design | Using the following versions of cobas infinity software (2.0 thorough 2.5), there is a potential where the results from the first sample subsequent to the bottle change, (when using the Standby bottle function), does not display a quality c | 15 units | 2020-09-16 |
| 2018-07-16 | Class II | Under Investigation by firm | Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamin | 12 units | 2019-05-16 |
| 2017-05-09 | Class II | Device Design | a gap between the conveyor belt and the rack tray table (plastic part) may cause vibration of the 5 position racks during the transport. This issue can pose a potential risk to involved operators and can also lead to potential cross contami | 3 | 2018-02-02 |
| 2017-03-01 | Class II | Under Investigation by firm | Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (BRF) modules with software version 02-xx, only when rack buffering i | 45 | 2018-07-03 |
| 2017-03-01 | Class II | Under Investigation by firm | “Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering | 45 Units | 2018-07-03 |
| 2016-12-27 | Class II | Software design | 5 | 2017-08-04 | |
| 2009-04-01 | Not classified | Component design/selection | Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware. | 498 of all products | 2009-12-07 |
| 2009-04-01 | Not classified | Component design/selection | Some data alarm flags do not transfer from the analyzer to the laboratory information system, since not all data flags are recognized by the instrument manager/middleware. | 498 of all products. | 2009-12-07 |
| 2003-06-26 | Not classified | Other | A software bug in version 3.0 may result in prolonged mixing time, evaporation of elution volume and biased sample results for various protocols. | 17 | 2003-11-19 |
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.