ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC20...
FDA Device Recall #Z-1146-2014 — Class II — January 20, 2014
Recall Summary
| Recall Number | Z-1146-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 20, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Horiba Instruments, Inc dba Horiba Medical |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 2,023 units |
Product Description
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.
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
Distribution Pattern
United States nationwide distribution.
Lot / Code Information
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.
Other Recalls from Horiba Instruments, Inc dba Horiba Me...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2286-2018 | Class II | ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, RE... | Apr 26, 2018 |
| Z-0494-2018 | Class II | 15 ML REAGENT CUP, B1037307, SAP 1221037307 for... | Nov 21, 2017 |
| Z-0493-2018 | Class II | 10 ML REAGENT CUP, B1034626, SAP 1221034626 for... | Nov 21, 2017 |
| Z-0902-2015 | Class II | ABX PENTRA Reagent Container, Model No. B103730... | Nov 13, 2014 |
| Z-2692-2014 | Class II | ABX PENTRA Magnesium RTU Reagent, Part No. A11A... | Aug 11, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.