FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
- Recall number
- Z-0645-2013
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Product
- ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
- Status
- Terminated
- Initiated
- 2012-09-20
- Posted
- 2013-01-07
- Terminated
- 2013-03-12
- Reason
- Horiba Medical is recalling ABX PENTRA ML because they have confirmed an issue with the ABX PENTRA ML data management and validation system. An incorrect patient result is transmitted to the Laboratory Information System. This result is from a previous run of the same patient that is stored in the ML database. This issue occurs in a very rare sequence of specific events. The affected software
- Root cause
- Software design
- Action
- .A recall letter dated 11/09/2012 was sent to all their customers who received the ABX PENTRA ML products. The letter informed the customers of the problem identified and the action to be taken. Customers are instructed to complete and return the enclose response form within 10 days. Customers with questions about the letter are instructed to contact their local HORIBA Medical representative. Recall Letter, as produced per FCD-0377, Field Safety Notice & Acknowledgement will be mailed via FedEx to the ten (10) customers noted on the list the week of November 12, 2012. Effectivity will be evaluated by receipt of the Field Safety Notice Acknowledgment Form. Follow-up communications with customers will be conducted, as needed.
- Quantity
- 10 units
- Distribution
- Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.
- Lot, serial or model codes
- Lot/Serial# PML0937
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JQP
- 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