Roche Diagnostics Operations, Inc.

Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

Lot Numbers 15622600, 15617800, 15616900 and 15816200.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

Lot Numbers 15617800, 15622600, 15616900 and 15621900.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution.

Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. || The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

Models: cobas b 123 <2> POC system: 05122252001 cobas b 123 < 4 > POC system: 05122287001 Serial numbers: 11074  2274  2550  2302  2304  2309  1253  2420  2337  2147  2389  2418  2425  1749  2462  2338  2339  1850  2328  2500  1374  2301  1349  2400  2344  2350  1860  1941  2006  2128

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution including CA, LA, NE, PR, SC, TX, VA, and WV

Cobas b 123 POC system || The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module and the oximeter module are available as an option

Lot Number(s): All lots within shelf life. Expiration Date(s): All

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the || Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system || The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate