Siemens Healthcare Diagnostics, Inc.: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543

Hazard

The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.

Details from the source

Reason for recall: The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents. Distribution: Worldwide - US Nationwide distribution in the states of CA, FL, GA, IA, IL, KY, LA, MS, NJ, NY, NV, PA, TX, VA, PR and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Chile, China, Columbia, Croatia, Cura¿ao, St Eus, Czech Republic, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, India, Ireland, Italy, Jordan, Kenya, Korea, K Quantity: 1,164 units (229 US, 935 OUS) Lot/code info: Siemens Material Number: 11097543; UDI-DI: 00630414279206; Lot number: 130414

UPC codes

00630414279206

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.