Tinaquant Hemoglobin A1c Gen2
Catalogue number 4528123190, listed by Roche Diagnostics Gmbh, Germany, under Assay, Glycosylated Hemoglobin. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K072714 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4528123190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinity Biotech | Primus Corp. | 36 |
| Variant II Turbo | Bio-Rad Laboratories Inc. | 15 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 7 |
| D-10 | Bio-Rad Laboratories Inc. | 7 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 5 |
| Drew Scientific | Drew Scientific, Ltd. | 5 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Corp. | 4 |
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Fructosamine | Roche Diagnostics Gmbh | 4 |
| D-10 Dual | Bio-Rad Laboratories Inc. | 3 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
Showing 12 of 134. All products under Assay, Glycosylated Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110313 | 2011-12-23 |
| K072714 | 2008-04-18 |
| K052464 | 2005-09-30 |
| K003120 | 2000-12-18 |
| K990992 | 1999-09-30 |
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 |
|---|---|---|---|---|---|---|---|
| Roche Diagnostics Operations | 510(k) number | 2016-10-04 | Class II | Storage | Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue occurred over multiple lots. Single cassettes/bottles | 4976 | 2017-06-05 |
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 |
|---|---|---|---|---|---|
| 2005-02-15 | Not classified | Other | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. | 1800 kits. | 2005-05-17 |
| 2005-02-15 | Not classified | Other | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. | 1800 kits. | 2005-05-17 |
| 2005-02-15 | Not classified | Other | The product is not uniform across the cassettes of some lots, which will result in an inconsistent bias of patient results. | 347,000 cassettes | 2005-05-17 |
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.