Accu-Chek Inform II Base Unit
2 catalogue numbers from 07828411001, listed by Roche Diagnostics Gmbh, Germany, under System, Test, Blood Glucose, Over The Counter. 20 manufacturers in China are registered for this product code.
20manufacturers in China registered for this device type
2catalogue numbers in this listing
19510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | Roche Diagnostics Gmbh, Germany |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K121679 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07828411001 | In distribution | |
| 07671717190 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141867 | 2015-03-03 |
| K133741 | 2014-08-29 |
| K133862 | 2014-04-29 |
| K130138 | 2013-03-15 |
| K113614 | 2013-02-12 |
| K121679 | 2012-10-11 |
| K113137 | 2012-01-06 |
| K081389 | 2008-07-15 |
| K070585 | 2007-05-25 |
| K062395 | 2007-05-09 |
| K060620 | 2006-08-11 |
| K032552 | 2003-09-12 |
| K022171 | 2002-07-23 |
| K021827 | 2002-07-03 |
| K021513 | 2002-06-11 |
| K021448 | 2002-06-03 |
| K012324 | 2001-12-05 |
| K012210 | 2001-08-09 |
| K011738 | 2001-06-20 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| Roche Diabetes Care, Inc. | 510(k) number | 2021-07-28 | Class II | Package design/selection | Test strip vials may open while inside sealed cartons during shipment. An open vial might expose the test strips to humidity, which might damage the strips and result in inaccurate results, potentially leading to inappropriate therapy decis | 9,555,555 (US); 5,128,758 (OUS) | |
| Roche Diagnostics Operations | 510(k) number | 2013-03-06 | Class II | Device Design | Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or | Both devices 4467 | 2018-01-10 |
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 |
|---|---|---|---|---|---|
| 2009-06-10 | Not classified | Process control | There may be a significant negative bias when testing neonate samples. | 1,518 of total products | 2010-10-29 |
| 2009-06-10 | Not classified | Process control | There may be a significant negative bias when testing neonate samples. | 1,518 of total products | 2010-10-29 |
| 2005-06-07 | Not classified | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample. | 2490 | 2007-07-02 |
| 2005-05-18 | Not classified | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for | 2005-12-12 | |
| 2005-05-18 | Not classified | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for | 2005-12-12 | |
| 2004-11-19 | Not classified | Other | A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa. | 4697 | 2005-06-07 |
| 2004-06-30 | Not classified | Other | Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke. | 2005-10-03 | |
| 2004-06-30 | Not classified | Other | Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke. | 2005-10-03 |
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.