CLASS II Device recall · Reported 12 Mar 2014 · FDA Enforcement Report
ABX Pentra Multical recalled by Horiba Instruments
Horiba Instruments is recalling ABX Pentra Multical, distributed nationwide in the US. The recall was initiated on 20 Jan 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-1146-2014
- FDA event ID
- 67332
- Recalling firm
- Horiba Instruments, Irvine, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jan 2014
- FDA classified
- 5 Mar 2014
- Reported
- 12 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 20 Jan 2014 | Recall initiated by company | |
| 5 Mar 2014 | Classified by FDA | +44 days |
| 12 Mar 2014 | 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
HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers
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
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.
Where it was distributed
United States nationwide distribution.
Stores named: Target
Questions about this recall
Why was it recalled?
HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P Control customers running the Creatinine Rate Blank Method assay on the ABX PENTRA 400 and PC200 that the Target Values for Creatinine Rate Blank Method have been updated. This issue is only applicable to Creatinine Rate Blank Method values reported on the ABX PENTRA 400 and PC200 Chemistry Analyzers only. No other analyzers
Which lots are affected?
Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654. Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601. Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.
Where was it sold?
United States 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.
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