SYNCHRON SYSTEMS SALICYLATE REAGENT

In-vitro diagnostics

Medical Device Safety Alert: Beckman Coulter Synchron Systems Salicylate Reagent

all lots

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution -- Australia, Bangladesh, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, Egypt, Eritrea, Finland, France, Germany, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Macau, Malaysia, Mayotte, Mexico, Netherlands, New Zealand, Oman, Pakistan, Panama, Paraguay, Philippines, Poland, Portugal, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, United States including Puerto Rico, and Vietnam.

Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. || Intended for quantitative determination of salicylate concentration in human serum or plasma.

Lot Numbers: M705222 and M706238.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Nationwide and Canada.

SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. || SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma.

Synchron Systems Salicylate Reagent. An in vitro diagnostic medical device (IVD)Reference Number: 378194All LotsARTG Number: 185654