FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
- Recall number
- Z-0493-2018
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Product
- 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
- Status
- Terminated
- Initiated
- 2017-11-21
- Posted
- not on file
- Terminated
- 2019-11-04
- Reason
- 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
- 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
- 10 bags, 100 units each
- Distribution
- Nationwide
- Lot, serial or model codes
- DATE - MVT 25.08.2017
- 510(k) numbers
- ["K052007"]
- PMA numbers
- not on file
- Product code
- JJE
- 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