Events

Recall of ABX PENTRA Calcium CP Reagent, Model A11A01633

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Horiba Instruments, Inc dba Horiba Medical.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66209
  • Event Risk Class
    Class 3
  • Event Number
    Z-2280-2013
  • Event Initiated Date
    2013-09-06
  • Event Date Posted
    2013-09-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121755
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cresolphthalein complexone, calcium - Product Code CIC
  • Reason
    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.
  • Action
    Horiba Medical sent an Urgent Safety Notice dated September 6, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer notification letter dated September 6, 2013 will be sent to all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent (Reference #: A11A01633) Lot#: 014664503. The recall letter informs the customers that the initial functional tests indicate that there is no interference identified with regards to the patient results. However, with time, there may be an increase in the quantity of precipitates and this could potentially interfere with the performance of this reagent. Customers are informed of the actions to be taken and to complete the customer response form within 10 days. Further questions please call (949) 453-0500 Ext. 208

Device

ABX PENTRA Calcium CP Reagent, Model A11A01633
  • Model / Serial
    Lot/Serial #(s): 014664503
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including the country of Canada.
  • 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.
  • Manufacturer
    Horiba Instruments, Inc dba Horiba Medical

Manufacturer

Horiba Instruments, Inc dba Horiba Medical
  • Manufacturer Address
    Horiba Instruments, Inc dba Horiba Medical, 34 Bunsen, Irvine CA 92618-4210
  • Manufacturer Parent Company (2017)
    Horiba Ltd.
  • Source
    USFDA