Horiba Medical Recalls ABX PENTRA Creatinine 120 CP Reagent
Horiba Medical is recalling ABX PENTRA Creatinine 120 CP reagent because a calibration alarm prevents the assay from being used.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a functional failure preventing use, not a safety hazard.
Plain-English summary
Horiba Instruments, Inc dba Horiba Medical is recalling 8,503 units of ABX PENTRA Creatinine 120 CP reagent. The affected product includes Model Number Creatinine Part # A11A01868 with Lot Numbers 203273706, 203273707, 203273808, and 203273709. The product was distributed nationwide.
The recall was initiated because some customers experienced a "REAG RANGE HIGH" alarm during Creatinine calibration. This alarm caused the calibration to fail, which prevented users from using the Creatinine assay. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay used for the quantitative determination of creatinine in human serum, plasma, and urine.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. Users should stop using the affected reagent and contact the manufacturer for instructions.
The recalled product
- Product
- ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine ba
- Manufacturer
- Horiba Instruments, Inc dba Horiba Medical
- Hazard
- Affected units
- 8,503
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Number Creatinine Part # A11A01868
- Lot Numbers: 203273706
- 203273707
- 203273808
- 203273709.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Horiba Instruments, Inc dba Horiba Medical
See all →- ModerateHoriba Medical Recalls ABX Pentra Micro Albumin Reagents Due to Result Elevation
FDA (Devices) · 2018-07-04
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups Due to Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Cups for Fit Issues
FDA (Devices) · 2018-02-07
- HighHoriba Medical Recalls ABX PENTRA Reagent Containers for Fit Issues
FDA (Devices) · 2015-01-14
- ModerateHoriba Medical Recalls ABX PENTRA Magnesium RTU Reagent for Stability Update
FDA (Devices) · 2014-10-01
Same hazard · functional failure
See all →- HighAccuVu Angiographic Catheter, Omni Flush, Non-Braided Defect Recall
FDA (Devices) · 2026-04-29
- HighSoftware Malfunction Disables Back Control on Baxter TruSystem 7500
FDA (Devices) · 2025-04-02
- HighBaxter TruSystem 7500 Hybrid software issue disables upper back adjustment
FDA (Devices) · 2025-04-02
- SevereCardiac catheters recalled due to polyurethane layer delamination defects
FDA (Devices) · 2024-05-22
- HighBard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction
FDA (Devices) · 2024-01-31