Model Numbers:Multical - A11A01652, N Control - A11A01653, P Control - A11A01654.  Lot Numbers: MultiCal: 1204101 and 1304901, N Control: 1300801, P Control: 1300601.  Expiration Date (s): MultiCal: 1204101 Expires on 05/31/14, MultiCal: 1304901 Expires on 07/15/15, N Control: 1300801 Expires on 11/05/14, P Control: 1300601 Expires on 11/05/14.

Clinical Chemistry and Clinical Toxicology Devices

2

No

United States nationwide distribution.

ABX PENTRA Multical. || ABX PENTRA N Control. || ABX PENTRA P Control. || The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two || measuring principals: absorbance and ion selective electrodes. || The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical || additives and materials of biological origin. The assigned values of the calibrator || components are given in the enclosed annex, ensuring optimal calibration of the || appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry || Analyzer. This calibrator is provided in ten vials of 3 ml.

Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A

Clinical Chemistry and Clinical Toxicology Devices

1

No

USA Nationwide Distribution

Device Name: ABX PENTRA ML || Model/Part #(s): A11A01652 || Lot/Serial #(s): N/A || Software Version(s): All versions are subject to this correction. || Product Usage: || The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.

Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide in US

ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)

Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution

ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. || The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. || ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.

Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels Low, Normal, and High).

Hematology and Pathology Devices

2

No

Nationwide Distribution

Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). || Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accuracy and precision on HORIBA Medical hematology blood cell counters using HORIBA Medical reagents. Minotrol 16 is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes, and platelets in a plasma-like fluid with preservatives. Minotrol 16 is a stable material that provides a means of determining the accuracy and precision of hematology blood cell counters. It is handled in the same manner as a patient specimen. The assay tables are determined on validated instruments using the appropriate reagents

Lot/Serial# PML0937

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide in the US, including the states of CA, MI, IN, FL, and GA. Center Recall Depth is Retail.

ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2

Lot number: 00456-4108

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

ABX PENTRA AST CP, Part Number: A11A01629. || The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.

Lot number: 00456-4108

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution including CA, OK, NY, FL, AZ, NY, VA, and TX.

PENTRA C200, Part Number: A11A01629. || The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and uring.

Lot/Serial #(s): 014664503

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including the country of Canada.

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.