HepCheck Whole Blood Control
HepCheck P214 - Abnormal 15/box
3manufacturers in China registered for this device type
2catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Shandong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
Record
| Listed by | Accriva Diagnostics, Inc., United States |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| 510(k) | K944691 |
| Record published | 2016-09-22 |
| Record revised | 2026-05-18 (version 6) |
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 35 to 46 °F; Storage environment temperature 2 to 8 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DCP214-A | 15 | In distribution | |
| DCP214-N | 15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| George King Pooled Normal Plasma | George King BIO-Medical, Inc. | 15 |
| directCHECK Whole Blood Controls | Accriva Diagnostics, Inc. | 12 |
| Thermo Scientific Pacific Hemostasis® | Fisher Diagnostics | 8 |
| Lyphochek | Bio-Rad Laboratories Inc. | 8 |
| George King Single Donor Normal Plasma | George King BIO-Medical, Inc. | 7 |
| Validate | LGC Clinical Diagnostics, Inc. | 6 |
| George King Coumadin® Plasma | George King BIO-Medical, Inc. | 5 |
| Plasma, Coagulation Control | Medtronic, Inc. | 5 |
| Liquichek | Bio-Rad Laboratories Inc. | 5 |
| CueSee® Coag | Eurotrol B.V. | 5 |
| Rotem® | TEM Innovations GmbH | 4 |
| CRYOcheck™ Pooled Normal Plasma | Precision BioLogic Inc. | 4 |
Showing 12 of 129. All products under Plasma, Coagulation Control
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| International Technidyne Corp. | 510(k) number | 2010-07-08 | Not classified | Error in labeling | Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. | 95 kits C9GC5001; 32 kits G9GC5003; 46 kits J9GC5004; 5 kits | 2010-09-23 |
| International Technidyne Corp. | 510(k) number | 2010-07-08 | Not classified | Error in labeling | Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published. | 101 kits | 2010-09-23 |
| International Technidyne Corp. | 510(k) number | 2010-06-25 | Not classified | Nonconforming Material/Component | The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes | 122 boxes in US, 1 out of US. | 2010-09-23 |
| Accriva Diagnostics, Inc. | 510(k) number | 2010-04-15 | Not classified | Error in labeling | Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect. | 94 boxes | 2010-09-23 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-04-30 | Class II | Process control | Assayed Whole blood control contains labeling with incorrect performance range. | 6060 |
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.