Horiba Instruments Inc
Horiba Instruments Inc appears in FDA public data with 9 recalls, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1553-2016, Class II) was initiated on February 19, 2016. Its most recent 510(k) clearance was granted on December 4, 1985.
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1553-2016 | Class II | ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric benc | February 19, 2016 |
| Z-1554-2016 | Class II | Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench t | February 19, 2016 |
| Z-0740-2016 | Class II | ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnost | January 11, 2016 |
| Z-0739-2016 | Class II | ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro | January 11, 2016 |
| Z-0742-2016 | Class II | ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative dete | January 11, 2016 |
| Z-0743-2016 | Class II | ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determi | January 11, 2016 |
| Z-0738-2016 | Class II | The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determ | January 11, 2016 |
| Z-0741-2016 | Class II | ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnost | January 11, 2016 |
| Z-0856-2015 | Class II | Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A | November 19, 2014 |