ABX PENTRA Reagent Container, Model No. B1037307 (15 mL)… recallZ-0902-2015 · Horiba Instruments, Inc dba Horiba Medical · initiated Nov 13, 2014
Class II Terminated All recalls posted in January 2015
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 400 Reagent Container because they 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. The defect would result in a false high or false low results for HbA1c and false high results for magnes
FDA root cause category: Package design/selection
What the company is doing
A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative.
Recall details
- Recall number
- Z-0902-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 13, 2014
- Posted by the FDA
- Jan 2, 2015
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Quantity
- 443 units
- Product code
- JJE
- FDA submissions
- K052007
- Distribution
- Nationwide in US
Product description
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Code information (models, lots, serial numbers)
Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.
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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