CLASS II Device recall · Reported 7 Feb 2018 · FDA Enforcement Report
Reagent Cup, B1034626, Sap 1221034626 for use recalled
Horiba Instruments is recalling Reagent Cup, B1034626, Sap 1221034626 for use with Abx Pentra 400 / Pentra C400, distributed nationwide in the US. The recall was initiated on 21 Nov 2017 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-0493-2018
- FDA event ID
- 78692
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Nov 2017
- FDA classified
- 31 Jan 2018
- Reported
- 7 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 21 Nov 2017 | Recall initiated by company | |
| 31 Jan 2018 | Classified by FDA | +71 days |
| 7 Feb 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The ABX PENTRA Reagent Containers 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.
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
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
The ABX PENTRA Reagent Containers 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.
Which lots are affected?
DATE - MVT 25.08.2017
Where was it sold?
Nationwide
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.
Other products in this recall event
1 other product · FDA event 78692| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reagent Cup, B1037307, Sap 1221037307 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
More recalls from Horiba Instruments
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Horiba custom configured fluorescence instrument recalled | Horiba Instruments | Foreign Material | Nationwide |
| Device | CLASS II | Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400 recalled | Horiba Instruments | Other | 40 states |
| Device | CLASS II | ABX Pentra Micro Albumin 2 CP, Serum/Plasma recalled | Horiba Instruments | Other | Nationwide |
| Device | CLASS II | Reagent Cup, B1037307, Sap 1221037307 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
| Device | CLASS II | ABX Pentra 400 recalled by Horiba Instruments | Horiba Instruments | Device Malfunction | Nationwide |
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| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |