Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT PENTRA C200, Part Number: A11A01629. The Pentra C200 system is a fully automated chemistry analyzer using colorimetry, turbidmetry and potentiometry technologies. It is mostly dedicated to in vitro diagnostic analyses based on homogeneous samples such as serum, plasma and urine....Read More

Company: Mindray DS USA Date of Enforcement Report 1/9/2013 Class ll: PRODUCT DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network...Read More

Company: Horiba Instruments, Inc dba Horiba Medical Date of Enforcement Report 1/9/2013 Class ll: PRODUCT ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry. Recall Number Z-0632-2013 REASON Horiba Medical is...Read More

Company: Abbott Molecular Date of Enforcement Report 1/9/2013 Class ll: PRODUCT Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL...Read More