Home / Recalls / Horiba Instruments, Inc dba Horiba Medical / Z-2280-2013

Z-2280-2013 Class III Terminated

Recalled by Horiba Instruments, Inc dba Horiba Medical — Irvine, CA

Recall Details

Product Type
Devices
Report Date
October 2, 2013
Initiation Date
September 6, 2013
Termination Date
August 23, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

Code Information

Lot/Serial #(s): 014664503

Other recalls by Horiba Instruments, Inc dba Horiba Medical

  • Z-2286-2018 Class II — ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is i (April 26, 2018)
  • Z-0493-2018 Class II — 10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA (November 21, 2017)
  • Z-0494-2018 Class II — 15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA (November 21, 2017)
  • Z-0902-2015 Class II — ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and (November 13, 2014)
  • Z-2692-2014 Class II — ABX PENTRA Magnesium RTU Reagent, Part No. A11A01646 Product Usage: ABX PENT (August 11, 2014)
  • Z-1173-2014 Class II — Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A So (February 14, 2014)
  • Z-1146-2014 Class II — ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PE (January 20, 2014)
  • Z-0924-2014 Class III — ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (December 18, 2013)
  • Z-0904-2014 Class II — ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use (November 21, 2013)
  • Z-1141-2013 Class II — HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE11 (March 20, 2013)