Variant II Hemoglobin A1c
VARIANT II Hemoglobin A1c Program Calibrator/Diluent Set
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | KRZ |
| Device type | Calibrator For Hemoglobin And Hematocrit Measurement |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8165 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070452 |
| Record published | 2016-09-12 |
| Record revised | 2023-01-31 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 270-2115NU | In distribution | |
| 270-2101NU | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CDS Hematology Calibrator | Clinical Diagnostic Solutions, Inc. | 2 |
| Cal-Chex | Streck LLC | 2 |
| Boule Cal | Clinical Diagnostic Solutions, Inc. | 1 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 1 |
| Architect | Abbott Laboratories | 1 |
| Advia® 120/2120/2120i SETpoint | Siemens Healthcare Diagnostics Inc | 1 |
| Advia® 360/560 Calibrator | Siemens Healthcare Diagnostics Inc | 1 |
| Cell-DYN | Abbott Laboratories | 1 |
| Cfas HbA1c | Roche Diagnostics Gmbh | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Bio-Rad Laboratories Inc. | 510(k) number | 2009-06-15 | Not classified | Other | Calibration Failure– due to high intercept values, the device fails calibration and users are unable to run samples. | 613 units | 2011-02-02 |
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 |
|---|---|---|---|---|---|
| 2011-10-25 | Not classified | Process control | It was discovered that the Variant II Turbo Link Calibrator Values card contains incorrect values for IFCC units. The numbers are missing a decimal point. | 63 | 2012-02-02 |
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.