Roche Diagnostics Corp.

Lot numbers: 60258801, 60258601, 60145701, 60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701, 69431901, 69357601, 69342001, 69246501, 68966601 and 68871601.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems, Roche Diagnostics, Inc., Indpls., IN; Catalog no. 04522320190. Product is an in vitro diagnostic.

All lots.

Hematology and Pathology Devices

2

No

Worldwide

CoaguChek brand PT Test Strips; U.S. Catalog Number 3116247 (48 strip pack-professional use), 3116239 (12 strip pack-patient self test), Non-U.S. Catalog Numbers 11937642190 [packaged 48 strips per box] and 11937634190 [packaged 12 strips per box].

Lots 175646 and 174558.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide.

Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.

All Lots with REF Numbers: 4861574019, 4861574020, 4861582014, 4861582019, 4861582020, 4861582034, 4862015023, 4862015027 and 4929381023.

Clinical Chemistry and Clinical Toxicology Devices

2

No

International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.

Roche ACCU-CHEK Performa blood glucose meters/kits, Roche Diagnostics, Indianapolis, IN. || Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.

All Lots with REF Numbers: 4861680020, 4861680023, 4861680031, 4861680039, 4861680053, 4861680136, 4862414003, 4862414016, 4862414020, 4862414023, 4862414031, 4862414039, 4862414053, 4862414136, 4862414170, 4948858020, 4948858039, 4948874031 and 5235243001.

Clinical Chemistry and Clinical Toxicology Devices

2

No

International Distribution -- Argentina, Australia, Brazil, Chili, China, Colombia, Ecuador, France, Germany, Great Britain, Hong Kong, India, Korea, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay and Venezuela.

Roche ACCU-CHEK Performa blood glucose test strips, Roche Diagnostics, Indianapolis, IN. || Test strips for quantitative blood glucose measurements in fresh capillary, arterial, or neonatal blood, as well as in heparin (lithium or sodium) or EDTA anticoagulated venous blood.