Beckman Coulter Inc.

All non-expired lots are affected by the recall.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution: USA and Canada

GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 725, UniCel DxC 600, UniCel DxC 600 PRO, UniCel DxC 600i, UniCel DxC 800, UniCel DxC 800 PRO, UniCel DxC 880i, UniCel DxC 680i, UniCel DxC 660i, and UniCel DxC860i ),

Lot Numbers: 911158, 911581, and 917631

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide and Canada

Access Immunoassay Systems AFP QC, Part Number: 33219 || The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.

Lot Numbers: 992751

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation

Active I-PTH ELISA, Part Number: DSL-10-8000 || The DSL-10-80000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism.

Lot Numbers: 090013, 090121, and 090372

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation

Active INTACT PTH, Part Number: DSL-8000 || The DSL-80000 ACTIVE Intact PTH IRMA Kit provides materials for the quantitative measurement of Intact PTH (I-PTH) in serum or plasma. The assay is intended for in vitro diagnostic use.

Lot numbers: 992637, 100115A, 100205A, 100205RA, 100226A, 100319A, 100409A, 100409RA

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution -- US, including states of CA, FL, GA, IL, IN, KS, MI, NC, NY, OH, OR, TX, VA, WA, and WI and country of Canada.

Estrone Radioimmunoassay (RIA) Kit, DSL-8700. || Intended for in vitro diagnostic use.