D-10 Dual
D-10 Dual Program HbA1c Calibrator/Diluent Set
1manufacturer
1catalogue number
1recall
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K041444 |
| Record published | 2016-09-12 |
| Record revised | 2023-01-31 (version 8) |
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 |
|---|---|---|
| 220-0128 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Laboratories | 15 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
Showing 12 of 391. All products under Calibrator, Secondary
Recalls Naming This Product
2 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 | 2011-07-11 | Not classified | Other | Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435. | 418 | 2012-03-12 |
| Bio-Rad Laboratories Inc. | 510(k) number | 2006-11-17 | Not classified | Other | The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results. | 900 kits, 43 sets distributed. | 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.