CLASS II Device recall · Reported 24 Apr 2013 · FDA Enforcement Report
Horiba Abx Pentra 400 I.s.e recalled by Horiba Instruments
Horiba Instruments is recalling Horiba Abx Pentra 400 I.S.E. Module, distributed nationwide in the US. The recall was initiated on 20 Mar 2013 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-1141-2013
- FDA event ID
- 64723
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Mar 2013
- FDA classified
- 18 Apr 2013
- Reported
- 24 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Medical Software
Timeline
| 20 Mar 2013 | Recall initiated by company | |
| 18 Apr 2013 | Classified by FDA | +29 days |
| 24 Apr 2013 | Published in enforcement report | +6 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 informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Numbers, Software Versions 5.0.7 and Below. Used to measure absorbance and ion electrodes.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
HORIBA Medical is informing all ABX PENTRA 400 Analyzer with I.S.E. Module customers that there are no Linearity Limit Flags for the I.S.E. assays currently programmed into the ABX PENTRA 400 Analyzer software. All other assays run on this analyzer do have Linearity Limit Flags to alert the user to values that fall below or above the validated linearity range for each assay.
Which lots are affected?
Model Numbers: P400ISE110EN02 and P400ISE110US02. All Serial Numbers. Versions 5.0.7 and below
Where was it sold?
Nationwide Distribution.
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
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 | Reagent Cup, B1034626, Sap 1221034626 for use recalled | Horiba Instruments | Device Malfunction | Nationwide |
Other Medical Software recalls
All 935| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Metatarsophalangeal (MTP) Implant is a sterile recalled by restor3d | restor3d | Sterility | Nationwide |
| Device | CLASS II | Ion Torrent Genexus Dx recalled by Life Technologies Holdings Pte | Life Technologies Holdings Pte | Device Malfunction | Nationwide |
| Device | CLASS II | Mulitple-type osteoarticular pathogen nucleic acid IVD, kit recalled | BioFire Diagnostics | Device Malfunction | Nationwide |
| Device | CLASS III | Kit: Urinary Clean Catch 20/cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Device Malfunction | CA |
| Device | CLASS II | Spectral CT and Spectral CT 7500 RT recalled by Philips Medical Systems | Philips Medical Systems | Device Malfunction | Nationwide |