Date Initiated by Firm | September 06, 2013 |
Date Posted | September 26, 2013 |
Recall Status1 |
Terminated 3 on August 23, 2014 |
Recall Number | Z-2280-2013 |
Recall Event ID |
66209 |
510(K)Number | K070249 |
Product Classification |
Cresolphthalein complexone, calcium - Product Code CIC
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Product | 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. |
Code Information |
Lot/Serial #(s): 014664503 |
Recalling Firm/ Manufacturer |
Horiba Instruments, Inc dba Horiba Medical 34 Bunsen Irvine CA 92618-4210
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For Additional Information Contact | 949-453-0500 Ext. 208 |
Manufacturer 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. |
FDA Determined Cause 2 | Under Investigation by firm |
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 |
Quantity in Commerce | 2,658 units ( 1240 US 1418 OUS ) |
Distribution | Worldwide Distribution - USA including the country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CIC
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