Immulite®/Immulite® 1000 Systems Sample Cups
IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
16manufacturers in China registered for this device type
1catalogue number
7recalls 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 | Siemens Medical Solutions Diagnostics, United States |
|---|---|
| FDA product code | JJE |
| Device type | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2160 |
| Record published | 2016-09-24 |
| Record revised | 2025-10-31 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10380037 | Withdrawn |
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
7 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 |
|---|---|---|---|---|---|
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 15 bottles | 2018-01-16 |
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 186 bottles | 2018-01-16 |
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 962 bottles | 2018-01-16 |
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 231 bottles | 2018-01-16 |
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 8 bottles | 2018-01-16 |
| 2015-03-05 | Class II | Nonconforming Material/Component | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the ca | 15 bottles | 2018-01-16 |
| 2014-02-03 | Class II | Device Design | There is a potential for incorrect results to be reported from processing of a sample tube. | 1006 units | 2016-06-30 |
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.