Z-1553-2016Class II

ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top...

Name: Z-1553-2016 ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top...
Creator: Horiba Instruments Inc
Published: 2016-02-19
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2016-02-19 / Terminated / root cause: software

FDA source

Horiba Instruments Inc began a 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. The device is... on 2016-02-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1553-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Posted: 2016-04-22
Terminated: 2016-08-17
Recalling firm: Horiba Instruments Incorporated
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: HORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it. Any questions or concerns contact the local Horiba Medical representative. For further questions, please call (949) 250-4811.
Quantity in commerce: 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.
Product codes and lots: All lot/serial #s

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1553-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1553-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22
Z-1554-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-04	2016-04-22

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)