Cell-DYN
CELL-DYN HemCal Plus Calibrator
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | KRY |
| Device type | Calibrator For Platelet Counting |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8175 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-06-06 |
| Record revised | 2025-11-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 10 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08H57-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Coulter S-CAL | Beckman Coulter, Inc. | 3 |
| Atellica Hema Calibrator | Siemens Healthcare Diagnostics Inc | 1 |
| Alinity | Abbott Medical | 1 |
| CDS-LTX Primer | Clinical Diagnostic Solutions, Inc. | 1 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-09-18 | Not classified | Other | Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results. | 4708 units | 2007-11-28 |
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.