Atellica Hema 580 Analyzer (SMS Ready)
Hematology Analyzer
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K232946 |
| Record published | 2026-02-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11315457 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162977 | 2017-08-11 |
| K102644 | 2011-11-23 |
| K090346 | 2010-07-28 |
Recalls
23 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 |
|---|---|---|---|---|---|
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 187 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 195 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 1 unit | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | ||
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 283 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 7 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 572 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 185 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 674 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 1 unit | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 1 unit | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 8 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 33 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 27 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 969 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 43 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 1452 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 132 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 32 units | |
| 2021-03-05 | Class II | Under Investigation by firm | Potential Sample Identification (SID) Mismatch with14-Character Barcodes | 15 units | |
| 2016-10-21 | Class II | Software design | Siemens is investigating an issue which may cause an incorrect result to be reported. Siemens received two reports of multiple discordant records for the same Sample ID in the ADVIA 560 Hematology System database that occurred during the in | US: 23 systems; Foreign: 141 systems | 2018-06-07 |
| 2016-03-10 | Class II | Process design | Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respect | US: 8 systems; Foreign: 64 systems | 2018-06-07 |
| 2013-08-12 | Class II | Software design | Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample id | 311 units total (US: 51 units; Foreign: 260 units) | 2015-11-18 |
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.