ABX PENTRA N Control, Model No. A11A01653 recallZ-0904-2014 · Horiba Instruments, Inc dba Horiba Medical · initiated Nov 21, 2013
Class II Terminated All recalls posted in January 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Horiba Instruments, Inc dba Horiba Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a revised Target Value assignment for Potassium.
FDA root cause category: Under Investigation by firm
What the company is doing
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
Recall details
- Recall number
- Z-0904-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 21, 2013
- Posted by the FDA
- Jan 31, 2014
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 698 units total (80 units in US)
- Product code
- JJY
- FDA submissions
- K052007
- Distribution
- Worldwide Distribution - USA (nationwide)
Product description
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.
Code information (models, lots, serial numbers)
Lot No. 1300801
Other devices under the same FDA submission
1 device cleared under K052007 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ABX PENTRA ETCHING CP 1220001769Horiba Abx Sas · Analyzer, Chemistry (Photometric, Discrete), For Clinical Use1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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