FDA Device recall Z-1553-2016
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use
- FDA Device
- Class II
- terminated
- Published 2016-05-04
On 2016-05-04 the FDA classified a Class II recall of ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use by Horiba Instruments, citing horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1553-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-19 |
| Published | 2016-05-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Horiba Instruments |
| Distribution | US |
Product
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Reason
Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
Identifiers
| code_info | All lot/serial #s |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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FDA Device · Class II · 2024-07-10 · Horiba Instruments - Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
FDA Device · Class II · 2019-10-16 · Horiba Instruments - ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure…
FDA Device · Class II · 2018-07-04 · Horiba Instruments - 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments - 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Device · Class II · 2018-02-07 · Horiba Instruments
All Horiba Instruments recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1553-2016%22
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