HITACHI

All lots containing 813401 as part of the lot number.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution (United States, Chile, India, Republic of Yemen and Trinidad).

Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. || The product is used for the quantitative determination of calcium in serum on Hitachi analyzers.

11021000, 11071000 and 11070900.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide distribution.

Acetaminophen Test System for use on the Roche/Hitachi, part number 03255379190, Roche Diagnostics Corporation, Indianapolis, IN. || For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers.

All lots of reagent when used manually or on the Roche/Hitachi 902, 911, 912, 917 or Modular Analytics P module analyzers.

United States, Canada and Germany

Roche/Hitachi brand lactate reagent for the quantitative determination of L-lactate in plasma, cerebrospinal fluid or whole blood. Catalog # 1822837.

Lots 725701-304, 727501-355, 727501-046, 727501-119 and 727501-205.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Canada, China, Romania and Trinidad.

Pointe Scientific Liquid Glucose HEX (R1) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R1. (Clinical chemistry)

Lots 727501-053 and 727501-070.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide, Canada, China, Romania and Trinidad.

Pointe Scientific Liquid Glucose HEX (R2) Reagent Set, Pointe Scientific, Inc, Canton, MI; Catalog # HG420-R2. (Clinical chemistry)