Starrsed
Semi-automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity with the Westergren standard.
4manufacturers in China registered for this device type
16catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shandong (3), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Shenzhen Yhlo Biotech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 19 |
Record
| Listed by | Mechatronics USA, United States |
|---|---|
| FDA product code | GKB |
| Device type | Device, Automated Sedimentation Rate |
| Device class | Class 1 |
| Regulation | 21 CFR 864.5800 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-12-05 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Sterilisation | Liquid Chemical |
| Supplied sterile | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026352 | In distribution | |
| A0030112 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution | |
| A0026376 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vision ESR Analyzer | Shenzhen Yhlo Biotech Co., Ltd. | 12 |
| Excyte® | ELITechGroup B.V. | 4 |
| Latex Controls | Alifax SRL | 4 |
| Latex EQE (2 Test) | Alifax SRL | 3 |
| Latex Calibrators | Alifax SRL | 2 |
| Starrsed Control | RR Mechatronics Manufacturing B.V. | 2 |
| Excyte® ESR Vacuum Tube, Carton | ELITechGroup Inc | 2 |
| ESR-Auto Plus | Streck LLC | 2 |
| Roller 20 | Alifax SRL | 2 |
| Sediplus® S 2000 NX | Sarstedt Aktiengesellschaft & Co.KG | 2 |
| Excyte 20 | ELITechGroup Inc | 2 |
| Monosed® ESR Vacuum Tubes, Carton | ELITechGroup Inc | 2 |
Showing 12 of 47. All products under Device, Automated Sedimentation Rate
Recalls
2 of these are Class III. 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 |
|---|---|---|---|---|
| 2023-04-14 | Class III | Labeling Change Control | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range. | 10752 units |
| 2023-04-14 | Class III | Labeling Change Control | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument result will be flagged as out of range. | 9306 units |
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.