ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell ...

FDA Device Recall #Z-2280-2013 — Class III — September 6, 2013

Recall Summary

Recall Number Z-2280-2013
Classification Class III — Low risk
Date Initiated September 6, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Horiba Instruments, Inc dba Horiba Medical
Location Irvine, CA
Product Type Devices
Quantity 2,658 units ( 1240 US 1418 OUS )

Product Description

ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.

Reason for Recall

HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.

Distribution Pattern

Worldwide Distribution - USA including the country of Canada.

Lot / Code Information

Lot/Serial #(s): 014664503

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-0493-2018 Class II 10 ML REAGENT CUP, B1034626, SAP 1221034626 for... Nov 21, 2017
Z-0494-2018 Class II 15 ML REAGENT CUP, B1037307, SAP 1221037307 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.