Abx Diagnostics
Country not established
- Devices
- 10
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Abx Diagnostics makes
Abx Diagnostics manufactures automated hematology analyzers, including instruments like the ABX MICROS 60, PENTRA 60, PENTRA 80, and PENTRA 120 series, designed for blood cell counting and reticulation analysis. Their portfolio also includes specialized modules such as the ABX MICROS CRP for C-reactive protein measurement and modifications for existing systems like the PENTRA 60C+. Additional models like the VEGA RETIC and MICROS 60 serve similar hematology functions in clinical settings.
These devices are classified under Class II by the FDA and are listed via the 510(k) pathway. The company is based in the United States, and its products are regulated under U.S. medical device authorities.
Catalogue
Abx Micros 60 Hematology Analyzer Ref K014203
Regimes: 510(k) Registry: 510(k)Modification To Pentra 60 And Pentra 60C+ Ref K030144
Regimes: 510(k) Registry: 510(k)Pentra 80 Ref K024002
Regimes: 510(k) Registry: 510(k)Abx Micros Crp Ref K002646
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Abx Pentra 60C+ Hematology Analyzer Ref K003677
Regimes: 510(k) Registry: 510(k)Abx Pentra 60 Hematology Analyzer Ref K992511
Regimes: 510(k) Registry: 510(k)Vega Retic Automated Hematology Analyzer Ref K990311
Regimes: 510(k) Registry: 510(k)Micros 60 Ref K030799
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Abx Diagnostics, the earliest on 2003-06-04 and the most recent on 2006-03-24. By recorded status: 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware and electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 24 Mar 2006 Z-1334-06 Unclassified (pre-2012) Terminated Labels can be incorrectly placed on a sample tube resulting in a possible error in results attributed to a sample.
2004
- 13 Aug 2004 Z-0002-05 Unclassified (pre-2012) Terminated Device can generate overestimated platelet results.
- 13 Aug 2004 Z-0003-05 Unclassified (pre-2012) Terminated Device can generate overestimated platelet results.
- 24 Jun 2004 Z-1342-04 Unclassified (pre-2012) Terminated Power failure having impact on software.
- 8 Apr 2004 Z-0298-06 Unclassified (pre-2012) Terminated Software defect, instrument may erroneously give a result of '0' or '---'.
2003
- 4 Jun 2003 Z-1149-03 Unclassified (pre-2012) Terminated Instrument fails to obtain correct patient information/results due to malfunction of the equipment's sample door.
Frequently asked questions
How many devices does Abx Diagnostics have in the registry?
The registry currently lists 10 devices for Abx Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Abx Diagnostics's devices?
Among its 10 most recently registered devices, Abx Diagnostics has devices listed in FDA 510(k) (10 devices).
What risk classes do Abx Diagnostics's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Abx Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Abx Diagnostics?
FDA recall records list 6 recalls initiated by Abx Diagnostics, the most recent initiated on 24 Mar 2006. 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 Abx Diagnostics in the registry?
The most recently registered devices listed for Abx Diagnostics include ABX MICROS 60 HEMATOLOGY ANALYZER, MODIFICATION TO PENTRA 60 AND PENTRA 60C+, PENTRA 80 and ABX MICROS CRP.