EZ1 Advanced
EZ1 Advanced: 1 catalogue number listed by Qiagen, Gmbh, Germany, under Clinical Sample Concentrator. 27 manufacturers in China are registered for this product code.
27manufacturers in China registered for this device type
1catalogue number
7recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (6), Guangdong (4). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Nanning Tecbod Biological Technology Co., Ltd. | Nanning | Guangxi | Contract manufacturer | 51 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Biomed Plastics Co. | Taicang | Jiangsu | Contract manufacturer | 29 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Changsha Renji Medical Equipment Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
| Jiangsu Macro & Micro-Test MED-Tech Co., Ltd. | Nantong | Jiangsu | Manufacturer | 11 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
Showing 12 of 27. All 27 manufacturers in China registered for Clinical Sample Concentrator
Record
| Listed by | Qiagen, Gmbh, Germany |
|---|---|
| FDA product code | JJH |
| Device type | Clinical Sample Concentrator |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2310 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-15 |
| Record revised | 2022-09-16 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TANBead Nucleic Acid Extraction Kit | Taiwan Advanced Nanotech Inc. | 124 |
| PCRopsis | Entopsis, Inc. | 53 |
| Bioer MagaBio plus Virus DNA /RNA Purification Kit III | Hangzhou Bioer Technology Co., Ltd. | 20 |
| m2000 | Abbott Molecular, Inc. | 19 |
| Allsheng | Hangzhou Allsheng Instruments Co., Ltd. | 13 |
| TANBead Nucleic Acid Extractor | Taiwan Advanced Nanotech Inc. | 12 |
| Bioer MagaBio plus Virus RNA Purification Kit II | Hangzhou Bioer Technology Co., Ltd. | 10 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 9 |
| BioTeke | Bioteke Corporation (Wuxi) Co., Ltd. | 8 |
| Prochem | Vivaproducts, Inc. | 8 |
| Vivafree 500 | Sartorius Stedim Lab Ltd. | 6 |
| Amicon Ultra → 4 | Merck Millipore Ltd. | 6 |
Showing 12 of 268. All products under Clinical Sample Concentrator
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2024-06-03 | Class II | Software design | Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria | 419 units | |
| 2024-03-04 | Class II | Under Investigation by firm | Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost | 168 units: 38 units US; 130 units OUS | |
| 2021-11-21 | Class II | Other | During the “Load tip racks and enzymes” step of the run set-up, the info screen indicates “minimal volume to be loaded”, but the indicated volume is instead the exact volume that should be loaded. Misunderstanding the guidance may lead to o | 93 US; 57 OUS | |
| 2019-07-02 | Class II | Software design | QIAsymphony software version 5.0.3 – Software issue incorreclty assigns the 2D bar code eluate ID to the sample within the results file. If 2D bar code eluate IDs are not checked against the sample ID prior to downstream application the inc | 417 | |
| 2019-06-05 | Class I | Process control | Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) | 1240 Kits | 2020-08-28 |
| 2018-07-23 | Class II | Nonconforming Material/Component | An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extracti | 298 | 2020-06-05 |
| 2018-05-28 | Class II | Under Investigation by firm | Underfilled reagent well that could lead to incorrect results | 287 pcs | 2019-04-05 |
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.