Accu-Chek Compact Plus
Accu-Chek Compact Plus Control L2 (Bio) The UDI information was not placed on the vial label due to the new kit guidance that was published.
Who Else Makes It
Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Roche Diagnostics Operations, United States |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Record published | 2016-08-26 |
| Record revised | 2019-04-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2018-10-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 06444393001 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Contour® | Ascensia Diabetes Care US Inc. | 10 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 8 |
| OneTouch Verio | Lifescan Europe Gmbh | 8 |
| Accu-Chek Aviva Plus | Roche Diagnostics Operations | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Accu-Chek Guide | Roche Diagnostics Operations | 7 |
| Contour® Next | Ascensia Diabetes Care US Inc. | 6 |
| Accu-Chek Smart View | Roche Diagnostics Operations | 6 |
| FreeStyle Lite | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131366 | 2013-10-11 |
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 | Closed |
|---|---|---|---|---|---|
| 2016-02-11 | Class II | Software Design Change | Accu-Chek Inform II Base Unit might produce physical transmission errors in the form of data loss in the communication between the meter and the Data Management Systems (DMS). The issue can lead to the data loss or in the worst case to an e | US 5,604 devices, OUS 91,925 | 2017-05-30 |
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.