CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report
ABX Pentra Reagent Container recalled by Horiba Instruments
Horiba Instruments is recalling ABX Pentra Reagent Container, distributed nationwide in the US. The recall was initiated on 13 Nov 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0902-2015
- FDA event ID
- 69773
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Nov 2014
- FDA classified
- 2 Jan 2015
- Reported
- 14 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 13 Nov 2014 | Recall initiated by company | |
| 2 Jan 2015 | Classified by FDA | +50 days |
| 14 Jan 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
Where it was distributed
Nationwide in US
Questions about this recall
Why was it 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
Which lots are affected?
Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.
Where was it sold?
Nationwide in US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Horiba Instruments
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|---|---|---|---|---|---|
| Device | CLASS II | Horiba custom configured fluorescence instrument recalled | Horiba Instruments | Foreign Material | Nationwide |
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| Device | CLASS II | Reagent Cup, B1037307, Sap 1221037307 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
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