GEM Check Coag Control-Normal for Aptt
Catalogue number 06260061600, listed by Instrumentation Laboratory SPA, Italy, under Plasma, Coagulation Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
3recalls 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 | Instrumentation Laboratory SPA, Italy |
|---|---|
| FDA product code | GGN |
| Device type | Plasma, Coagulation Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5425 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K944691 |
| Record published | 2016-09-23 |
| Record revised | 2026-05-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2024-01-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 06260061600 | 15 | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K133582 | 2014-08-15 |
| K113211 | 2012-01-04 |
| K090563 | 2009-10-09 |
| K082859 | 2008-12-19 |
| K030965 | 2003-06-06 |
| K021024 | 2002-05-16 |
| K021022 | 2002-05-14 |
| K021023 | 2002-05-14 |
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
3 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2013-11-15 | Class II | No Marketing Application | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 84561 kits | 2014-03-25 |
| 2013-11-15 | Class II | No Marketing Application | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 80319 Kits | 2014-03-25 |
| 2013-11-15 | Class II | No Marketing Application | HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval | 6504 kits | 2014-03-25 |
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.