FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: 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.
- Recall number
- Z-2286-2018
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- 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.
- Status
- Terminated
- Initiated
- 2018-04-26
- Posted
- not on file
- Terminated
- 2019-09-26
- Reason
- 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
- 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: azita.hedayati@horiba.com 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
- 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.
- Lot, serial or model codes
- All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- PFT
- Firm FEI
- 3002698356
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28