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

Hazard

Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.

Details from the source

Reason for recall: Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark, Egypt, Estonia, Ethiopia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Macedon Quantity: 11,811 units Lot/code info: Material Number: 11097543. Test Code: UCFP. UDI-DI: 00630414279206. All lot numbers.

UPC codes

00630414279206

Source

Official record: FDA (Device enforcement) ↗

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