Z-0902-2015Class II

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

Name: Z-0902-2015 ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2014-11-13
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-11-13 / Terminated / root cause: packaging

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) on 2014-11-13. FDA classified it as Class II and gives the reason as "HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0902-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-13
Posted: 2015-01-02
Terminated: 2015-03-19
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they 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. The defect would result in a false high or false low results for HbA1c and false high results for magnes
Root cause tag: packaging
FDA root cause: Package design/selection
Action: A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative.
Quantity in commerce: 443 units
Distribution: Nationwide in US
Product codes and lots: Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0902-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0902-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-02

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)