Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part...
FDA Device Recall #Z-0119-2020 — Class II — October 30, 2018
Recall Summary
| Recall Number | Z-0119-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 30, 2018 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Horiba Instruments Incorporated |
| Location | Irvine, CA |
| Product Type | Devices |
| Quantity | 1539 Chemistry Analyzers |
Product Description
Clinical Chemistry, ABX Pentra Lipase CP, ABX Pentra 400/Pentrac400, REF: A11A01631, Model/Part # 1220001631, UDI # 03610230004944
Reason for Recall
Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could be observed and a patient result could be declared abnormal by the instrument due to these interferences instead of normal result < 38 U/L (or < reference value used in your laboratory).
Distribution Pattern
US: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY
Lot / Code Information
All Lots; All Software versions
Other Recalls from Horiba Instruments Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2166-2024 | Class II | HORIBA custom configured fluorescence instrumen... | Mar 28, 2024 |
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.