Variant II Turbo Link
VARIANT II TURBO Link Hemoglobin A1c Program Calibrator/Diluent Set
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 | 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) | K070819 |
| 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 |
|---|---|---|
| 270-2722 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CDS Hematology Calibrator | Clinical Diagnostic Solutions, Inc. | 2 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 2 |
| Cal-Chex | Streck LLC | 2 |
| Boule Cal | Clinical Diagnostic Solutions, 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
5 recalls name this product by its own identifiers, 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 | 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 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 120 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-09-12 | Not classified | Process control | A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these produc | 40 | 2012-05-11 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2011-07-28 | Not classified | Employee error | The Elution Buffer B, lot no. GA 10430, was shipped in a 2.0 L bottle instead of the standard 2.5 L bottle. | 40 | 2011-11-01 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2010-02-19 | Not classified | Nonconforming Material/Component | The results from the blood device had the occurrence of some ramping baselines on their chromatograms. The ramping baseline can affect quantitation of the blood results. | 27 | 2011-03-03 |
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.