Chek-Stix® Combo Pak Control+ Control- Strips
Quality control for Siemens urine strips read visually and all analyzers other than Clinitek Atlas® and Clinitek Novus® - 25 positive and 25 negative strips
3manufacturers in China registered for this device type
1catalogue number
7recalls on this code
Who Else Makes It
Concentrated in Jilin (1), Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JJW |
| Device type | Urinalysis Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K931467 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep out of direct sunlight; Storage environment temperature 15 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10310483 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kova | Kova International Inc | 52 |
| Urine Control | Chromsystems Instruments & Chemicals Gmbh | 16 |
| Urinalysis Controls (Assayed And Unassayed) | Alta Diagnostics, Inc. | 14 |
| Cardinal Health | Cardinal Health 200, LLC | 10 |
| qUAntify | Bio-Rad Laboratories Inc. | 10 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| DxU | Beckman Coulter, Inc. | 6 |
| Cardinal Health | Kova International Inc | 6 |
| MAS UA Control Liquid Assayed Urinalysis Control | Microgenics Corporation | 5 |
| Quality Control Solution For Urine Analyzer | Urit Medical Electronic Co., Ltd. | 4 |
| Urine Control Bi-Level | Chromsystems Instruments & Chemicals Gmbh | 4 |
| Mission Liquid Urine Controls | Acon Laboratories, Inc. | 4 |
Showing 12 of 77. All products under Urinalysis Controls (Assayed And Unassayed)
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 6466 | 2014-11-06 |
| 2012-11-21 | Class II | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 1130 | 2014-11-06 |
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 700 | 2014-11-06 |
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 4642 | 2014-11-06 |
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 7865 | 2014-11-06 |
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 325 | 2014-11-06 |
| 2012-11-21 | Class III | Nonconforming Material/Component | When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). | 16711 | 2014-11-06 |
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.