FreeStyle Freedom
FreeStyle Freedom Blood Glucose Monitoring System
20manufacturers in China registered for this device type
1catalogue number
19510(k) clearances naming this product code
35recalls 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 | Abbott Diabetes Care Limited, United Kingdom |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K152442 |
| Record published | 2016-08-12 |
| Record revised | 2023-10-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 40 to 86 °F |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11004 | 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 |
|---|---|
| K171941 | 2017-09-27 |
| K153330 | 2016-02-19 |
| K142928 | 2015-09-30 |
| K140371 | 2014-09-30 |
| K132511 | 2013-12-24 |
| K130094 | 2013-06-27 |
| K120568 | 2012-03-29 |
| K092638 | 2010-06-15 |
| K092602 | 2010-05-14 |
| K081975 | 2008-11-26 |
| K080960 | 2008-09-05 |
| K070850 | 2007-04-10 |
| K062770 | 2006-12-14 |
| K051839 | 2006-03-09 |
| K051802 | 2005-08-09 |
| K050500 | 2005-06-27 |
| K031260 | 2003-12-19 |
| K020866 | 2002-06-11 |
| K012014 | 2001-12-05 |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2019-11-14 | Class II | Labeling False and Misleading | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to | 2021-04-28 | |
| 2019-11-14 | Class II | Labeling False and Misleading | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to | 2021-04-28 | |
| 2014-02-19 | Class I | Material/Component Contamination | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when | not provided. Device has not been shipped in the last 5 year | 2015-08-11 |
| 2014-02-19 | Class I | Material/Component Contamination | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when | 25,203 units | 2015-08-11 |
| 2013-11-18 | Class I | Other | Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter bui | 141,219 cartons for human use – total | 2015-08-03 |
| 2013-11-18 | Class I | Other | Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low blood glucose results when using FreeStyle Blood Glucose Meters, FreeStyle Flash Blood Glucose Meters and the FreeStyle blood glucose meter bui | 141,219 cartons for human use – all lot numbers | 2015-08-03 |
| 2013-04-15 | Class I | Software design | AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading. | 335,273 meters; 209,336 remain at firm. | 2015-08-03 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot. | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot. | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot. | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot. | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots of 1,000,000 strips each. | 2011-10-25 |
| 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot. | 2011-10-25 |
| 2009-06-10 | Not classified | Process control | Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters. | 9,252 vials | 2011-01-10 |
| 2009-03-13 | Not classified | Other | Product dispositioned for destruction was potentially diverted to end users. | 1860 units | 2011-02-15 |
| 2007-08-02 | Not classified | Component design/selection | Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to comp | 882,601 total meters distributed, 316,439 in the U.S. and 56 | 2011-03-28 |
| 2007-03-05 | Not classified | Other | The front button covers may detach from the meter. | approximately 300 lots | 2008-04-04 |
| 2006-12-18 | Not classified | Other | If the time and date are not set correctly on both the user’s meter and computer, there is the potential for incorrect times and dates to be assigned to the results in the Precision Link Software. | 67,601 units | 2010-12-20 |
| 2006-05-22 | Not classified | Other | The products may encounter display problem, ‘Er 4’ message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selec | 2,365,000 meters (approx.-both types | 2006-12-21 |
| 2006-05-22 | Not classified | Other | The products may encounter display problem, ‘Er 4’ message, during prolonged use when the low battery symbol is displayed. The situation can render the meter either inoperable or operable with invalid user configuration data including selec | approx. 2,365,000 meters (both recall numbers) | 2006-12-21 |
| 2006-02-17 | Not classified | Other | The device may give inaccurate elevated blood glucose test results. This may lead to over treatment and hypoglycemic complications may result. | 900 | 2011-01-20 |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 | |
| 2005-06-07 | Not classified | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. | 2006-05-17 |
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.