Nipro Diagnostics, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
- FDA recalls
- 3
At a glance
Market reach
- United States
- FDA recalls
What Nipro Diagnostics, Inc. makes
Nipro Diagnostics, Inc. manufactures self-monitoring blood glucose systems for both personal and professional use, including the TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM and the TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM. The company also produces the TRUE METRIX AIR Self-Monitoring Blood Glucose System and the TRUE METRIX AIR PRO Professional Blood Glucose Monitoring System, designed for continuous glucose monitoring.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
True Metrix Self-Monitoring Blood Glucose System, True Metrix Professional Monitoring Blood Glucose System Ref K120989
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 3 recalls initiated by Nipro Diagnostics, Inc., the earliest on 2013-02-25 and the most recent on 2013-10-02. By recorded status: 3 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2013
- 2 Oct 2013 Z-0909-2014 Class II Terminated Manufactured with an incorrect factory set unit of measure.
Full distribution text
- 2 Oct 2013 Z-0910-2014 Class II Terminated Manufactured with an incorrect factory set unit of measure.
Full distribution text
- 25 Feb 2013 Z-1140-2013 Class II Terminated Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.
- 2 Oct 2013 Z-0909-2014 Class II Terminated Manufactured with an incorrect factory set unit of measure.
Frequently asked questions
How many devices does Nipro Diagnostics, Inc. have in the registry?
The registry currently lists 4 devices for Nipro Diagnostics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Nipro Diagnostics, Inc.'s devices?
Among its 4 most recently registered devices, Nipro Diagnostics, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Nipro Diagnostics, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Nipro Diagnostics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Nipro Diagnostics, Inc.?
FDA recall records list 3 recalls initiated by Nipro Diagnostics, Inc., the most recent initiated on 2 Oct 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Nipro Diagnostics, Inc. in the registry?
The most recently registered devices listed for Nipro Diagnostics, Inc. include TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System and TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM.