Class II — Horiba Instruments Inc
| Recalling firm | HORIBA INSTRUMENTS INCORPORATED (DBA) HORIBA Medical |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 201 |
| Distribution | USA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC. |
| Initiated | 2016-02-19 |
| Classified | 2016-04-22 |
| Terminated | 2016-08-17 |
| Recall number | Z-1553-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Horiba Instruments Inc (Z-1553-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73349/
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