Alinity M
Alinity m HCV Application Specification File
15manufacturers in China registered for this device type
20catalogue numbers in this listing
1510(k) clearance
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (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 |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Bioteke Corporation (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 21 |
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
| Xian Tianlong Science AND Technology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Hangzhou Bioer Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 6 |
| Sansure Biotech Inc. | Changsha | Hunan | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Real Time Nucleic Acid Amplification System
Record
| Listed by | Abbott Molecular, Inc., United States |
|---|---|
| FDA product code | OOI |
| Device type | Real Time Nucleic Acid Amplification System |
| Device class | Class 2 |
| Regulation | 21 CFR 862.2570 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K202977 |
| Record published | 2020-06-10 |
| Record revised | 2025-10-01 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 8, case of 4, case of 10, pack of 50, box of 4, case of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 09N20-001 | In distribution | ||
| 09N26-002 | 480 | In distribution | |
| 09N20-004 | In distribution | ||
| 09N26-015 | In distribution | ||
| 09N26-016 | 12 | In distribution | |
| 09N50-001 | In distribution | ||
| 08N53-002 | In distribution | ||
| 09N26-014 | 10 | In distribution | |
| 09N26-013 | In distribution | ||
| 09N12-001 | In distribution | ||
| 09N26-010 | 20 | In distribution | |
| 09N19-012 | In distribution | ||
| 08N50-03B | In distribution | ||
| 09N26-019 | 2 | In distribution | |
| 09N26-004 | 4 | In distribution | |
| 09N20-003 | In distribution | ||
| 09N26-001 | 480 | In distribution | |
| 09N26-003 | In distribution | ||
| 09N26-020 | 10 | In distribution | |
| 09N26-012 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GeneXpert Dx System | Cepheid | 37 |
| GeneXpert Infinity-80 System | Cepheid | 13 |
| Fluorescence Quantitative PCR Detection System | Anitoa Biotechnology(Hangzhou)Co., Ltd. | 12 |
| GeneXpert® | Cepheid | 10 |
| Certified Pre-Owned GeneXpert Dx System | Cepheid | 10 |
| Bioer GeneExplorer Thermal Cycler | Hangzhou Bioer Technology Co., Ltd. | 7 |
| m2000 | Abbott Molecular, Inc. | 5 |
| GeneXpert Infinity-48s System | Cepheid | 5 |
| Panther Fusion® | Hologic, Inc. | 4 |
| Bioer LineGene 9600 Plus Fluorescent Quantitative Detection System | Hangzhou Bioer Technology Co., Ltd. | 4 |
| Bioer QuantGene 9600 Fluorescent Quantitative Detection System | Hangzhou Bioer Technology Co., Ltd. | 3 |
| Q-Vera Prima 96 qPCR Instrument | Sansure Biotech Inc. | 3 |
Showing 12 of 188. All products under Real Time Nucleic Acid Amplification System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092705 | 2010-05-28 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Molecular, Inc. | UDI-DI | 2025-03-20 | Class II | Device Design | The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the use | ||
| Abbott Molecular, Inc. | UDI-DI | 2022-11-11 | Class II | Under Investigation by firm | The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a poten | 1 | |
| Abbott Molecular, Inc. | UDI-DI | 2022-02-11 | Class II | Under Investigation by firm | There is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot. | 3063 kits | 2023-04-14 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2024-03-20 | Class II | Under Investigation by firm | The Alinity m System camera detects whether tubes are “capped.” If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message ‘Error – 6013: Has cap, no retention bar.” Abbott has | 1,012 units | |
| 2024-02-01 | Class III | Process control | Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers. | ||
| 2022-12-09 | Class II | Under Investigation by firm | The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced | 918 units | |
| 2022-10-12 | Class II | Under Investigation by firm | Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found to not open when the Systems Solution drawer was closed and locked. It was foun | 883 units | |
| 2011-09-08 | Not classified | Software design | The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column he | 926 units | 2016-03-08 |
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.