Z-2692-2014Class II

ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646

Name: Z-2692-2014 ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2014-08-11
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2014-08-11 / Terminated / root cause: labeling and UDI

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for... on 2014-08-11. FDA classified it as Class II and gives the reason as "Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2692-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-11
Posted: 2014-09-24
Terminated: 2014-11-25
Recalling firm: Horiba Instruments Incorporated
Product: ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENTRA Magnesium RTU reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of magnesium in human serum and plasma based on a photometric test using xylidyl blue. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemnia (abnormally low plasma levels of magnesium) and hypermagnesemnia (abnormally high plasma levels of magnesium).
Product code: JGJ Photometric Method, Magnesium
Reason for recall: Horiba Medical is recalling the ABX PENTRA Magnesium RTU Reagent because the on-board stability claims has been updated. Horiba has updated the ABX PENTRA Magnesium RTU package inserts by removing the 7-day on-board stability claim and replacing it with a 1-day on-board stability claim.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Horiba sent an Urgent Safety Notice letter dated August 11, 2014 to all customers running the Magnesium RTU assay on the ABX PENTRA 400 Chemistry analyzers that the On-Board Stability has been updated. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. For questions call 888-903-5001, ext 4266.
Quantity in commerce: 359 units
Distribution: US Nationwide Distribution.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2692-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2692-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-23

Product code JGJ

K060205Class IIGeneral Chemistries on Abx Pentra 400 Clinical Chemistry AnalyzerHoriba Abx / cleared 2006-07-21

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)