Z-0493-2018Class II

10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400

Name: Z-0493-2018 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2017-11-21
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2017-11-21 / Terminated / root cause: manufacturing process

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 on 2017-11-21. FDA classified it as Class II and gives the reason as "The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0493-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-21
Posted: 2018-01-31
Terminated: 2019-11-04
Recalling firm: Horiba Instruments Incorporated
Product: 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated their recall by letter on 11/21/2017. The letter stated the following: "A new production of reagent container compliant for each reference is under process and will be made available very soon. In the meantime and to allow a proper operating of the analyzer ABX PENTRA 400 / PENTRA C400, it Is necessary to push the reagent containers in the reagent racks until they touch the bottom of the rack. Please share this information with your laboratory staff, and retain this notification as part of your Quality System documentation. It is mandatory for you to complete and return the enclosed response form within 10 days so we may maintain our records."
Quantity in commerce: 10 bags, 100 units each
Distribution: Nationwide
Product codes and lots: DATE - MVT 25.08.2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0493-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0493-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-31
Z-0494-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-07	2018-01-31

Product code JJE

K052007Class IIAbx Pentra 400 Clinical Chemistry Analyzer (Option: I.s.e. Module)Horiba Abx / cleared 2005-12-16

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)