FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
- Recall number
- Z-0904-2014
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Product
- ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
- Status
- Terminated
- Initiated
- 2013-11-21
- Posted
- 2014-01-31
- Terminated
- 2014-10-28
- Reason
- Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
- Root cause
- Under Investigation by firm
- Action
- Horiba sent an customer notification letter dated November 32, 2013, to all affected customers. The letter was sent via email to all customers who purchased the ABX PENTRA 400. HORIBA Medical is informing all ABX PENTRA N Control customers running the Potassium-E assay on the ABX PENTRA 400 with I.S.E. Module that the Target Value and Target Range for Potassium has been updated. The letter informs the customers of the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days by fax (949) 453-0600 Customers with questions are instructed to contact their local HORIBA Medical representative. For further questions please call (949) 453-0500 X 208
- Quantity
- 698 units total (80 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide)
- Lot, serial or model codes
- Lot No. 1300801
- 510(k) numbers
- ["K052007"]
- PMA numbers
- not on file
- Product code
- JJY
- 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
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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