Z-2286-2018Class II

ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction...

Name: Z-2286-2018 ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction...
Creator: Horiba Instruments, Inc dba Horiba Medical
Published: 2018-04-26
License: https://open.fda.gov/license/

Horiba Instruments Incorporated / initiated 2018-04-26 / Terminated / root cause: design

FDA source

Horiba Instruments, Inc dba Horiba Medical began a recall of ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of... on 2018-04-26. FDA classified it as Class II and gives the reason as "When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2286-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-26
Posted: 2018-06-25
Terminated: 2019-09-26
Recalling firm: Horiba Instruments Incorporated
Product: ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Product code: PFT Reagents For Molecular Diagnostic Test Systems
Reason for recall: When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Horiba Medical, sent a "FIELD SAFETY NOTICE" dated April 26, 2018 to the customers on the customer list on April 26, 2018. The notice described the product, problem and actions to be taken. The notice directed the consignee to manually program the system to address the issue and the share the information with the laboratory staff and to complete and return the enclosed Acknowledgment Form within 10 days via Fax: (949)753-0533, Email: [email protected] or Mail: HORIBA Medical, 9755 Research Dr., Irvine, CA 92618. If you have any questions regarding this Product Corrective Action, please contact your local Horiba Medical representative or our Technical Service Department at 888-903-5001, option 3, option 2.
Quantity in commerce: 686 devices (233 devices US, 453 devices OUS)
Distribution: Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand.
Product codes and lots: All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2286-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2286-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-25

Product code PFT

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)