Horiba Instruments, Inc dba Horiba Medical: Medical Device Recall in 2013 - (Recall #: Z-2280-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: September 6, 2013

Date Posted: October 2, 2013

Recall Number: Z-2280-2013

Event ID: 66209

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.

Status: Terminated

Product Quantity: 2,658 units ( 1240 US 1418 OUS )

Code Information:

Lot/Serial #(s): 014664503

Distribution Pattern:

Worldwide Distribution - USA including the country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated