Siemens Healthcare Diagnostics, Inc.: Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

Hazard

Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.

Details from the source

Reason for recall: Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result. Distribution: Domestic: Nationwide Distribution. International: Australia, Austria, Bahamas, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Cura¿ao,¿St¿Eus, Czech¿Republic, Denmark,¿Estonia, Finland, France, Germany, Greece,¿Hong Kong, Hungary, India, Ireland, Israel, Italy, Korea, Kuwait, Latvia, Lithuania, Malaysia, Maldives, Netherlands, New Zealand, Norway, Oman,¿Pakistan, Poland, Portug Quantity: N/A Lot/code info: Siemens Material Number (SMN): 11537223; UDI-DI: 00630414610887; Lot numbers: All lots.

UPC codes

00630414610887

Source

Official record: FDA (Device enforcement) ↗

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