| Z-0017-2012 |
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests;
For the determination of Hemoglobin A1c in human whole blood. IVD
Contents:
1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer
2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer
3. Wash/Diluent 1 x 1600 mL Deionized water
4. Analytical cartridge - 1 cation exchange cartridge
5. Floppy Diskette 1-program parameters
6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water.
7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative.
8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid
9 Thermal paper - 1 roll
10. Instruction manual
Made in United States
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
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2011-09-12 |
Terminated
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View Details
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| Z-0018-2012 |
D-10 Hemoglobin A1c Supplemental Reagent Pack:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
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2011-09-12 |
Terminated
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View Details
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| Z-0019-2012 |
D-10 Hemoglobin A1c Program Elution Buffer 2:
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
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2011-09-12 |
Terminated
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View Details
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| Z-0020-2012 |
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer
3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges.
4. CD-ROM 1 - CD Rom with program parameters
5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water.
6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative,
7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps.
8. Instruction Manual.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
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View Details
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| Z-0021-2012 |
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests,
IVD, Made in United States.
Kit contains:
1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer
2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer
3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges.
4. CD-ROM 1 - CD Rom with program parameters
5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water.
6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative,
7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps.
8. Instruction Manual.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
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2011-09-12 |
Terminated
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View Details
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| Z-0022-2012 |
VARIANT II TURBO Hemoglobin A1c Program Buffer B,
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
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2011-09-12 |
Terminated
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View Details
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| Z-0023-2012 |
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States.
Contents:
1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer
2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer
3. Wash/Diluent solution, 1 x 1800 mL deionized water
4. Analytical cartridge, 1 cation exchange cartridge
5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative
6. 1 CD Rom - CD R with program parameters
7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap
8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative;
9. Instruction Manual
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
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View Details
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| Z-0024-2012 |
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States.
Contents:
1. Elution Buffer 1, 3 x 1900 mL sodium phosphate buffer
2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer
3. Wash/Diluent solution, 2 x 1800 mL deionized water
4. Analytical cartridge, 1 cation exchange cartridge
5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative
6. 1 CD Rom - CD R with program parameters
7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap
8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative;
9. Instruction Manual
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
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View Details
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| Z-0025-2012 |
VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
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View Details
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| Z-0026-2012 |
VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set.
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
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View Details
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| Z-0027-2012 |
VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests.
For the determination of Hemoglobin A1c in human whole blood.
Contents:
1. Elution Buffer A, 1 x 2500 mL Bis-Tris Phosphate Buffer
2. Elution Buffer B, 1 x 2100 mL Bis-Tris Phosphate Buffer
3. Wash/Diluent Solution, 1 x 2500 mL, Deionized water
4. Cartridge set - 2 cations exchange Analytical Cartridges, 4 cation exchange guard cartridges
5. CD-ROM 1, CD Rom with program parameters
6. Calibrator/Diluent Set, 2 levels, 2 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle of diluent, 100 mL deionized water.
7. Whole Blood Primer, 6 x 1 mL, Lyophilized human red blood cell hemolysate with preservative
8. Sample Vials, 2 x 100, Polypropylene vials with pierceable lids
9. Instruction Manual.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Made in United States.
Bio-Rad Laboratories, Hercules, CA 94547.
Reason: A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
|
2011-09-12 |
Terminated
|
View Details
|