Device Recall BD Vacutainer

Catalog (Ref) # 367856; Lot Number 5014806

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, Indonesia, Malaysia and South Korea.

BD Vacutainer K2 EDTA (K2E) 5.4mg Plus Blood Collection Tubes. || Product Usage: || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening. The performance characteristics of these tubes have not been established for immunohematology testing in general: therefore, users must validate the use of these tubes for their specific assay-instrument/reagent system combinations and specimen storage conditions.

Catalog Reference #367842; Lot numbers 5089731 and  5175923

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA || The Vacutainer Brand PLUS (Plastic) Tube with EDTA Vacutainer¿ Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube.

Catalog Reference #368047; Lot number 5154647

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory.The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Catalog Reference #368054; Lot numbers 5089827, 5210514, 5154646, 5210511.  Catalog Reference #367856; Lot number 5064666

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Lavender) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.

Catalog Reference #367855; Lot numbers 5064684, 5120653, 5154643, 5175930, 5210765, 5237787

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: US (Nationwide) and the countries of: European Union, Peoples Republic of China, Japan and Republic of Korea.

BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x || 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg Sterile IVD BD, Made in USA || BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing serum, plasma or whole blood in the clinical laboratory. The BD Vacutainer¿ Plus K2EDTA Tubes may be used for routine immunohematology testing and blood donor screening.