Siemens Healthcare Diagnostics Inc: epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configuration: epoc Host

Hazard

The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n.

Details from the source

Reason for recall: The occurrence of discrepant high pH results in samples introduced with higher injection volumes with epoc sensor configuration 45.n. Distribution: Domestic: Nationwide Distribution; Foreign: Albania, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Brazil, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Ecuador, Estonia, France, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lithuania Quantity: 264,252 units Lot/code info: Siemens Material Number (SMN): 10736515; Udi-DI: 00809708121860; Lot Numbers: All lot numbers with prefix (xx) 02 or 12; epoc Software Version and Senor Configuration: epoc Host SW V3.41.2, epoc NXS SW v4.14.9 & 4.14.11, Sensor Configuration 45.n.

UPC codes

00809708121860

Source

Official record: FDA (Device enforcement) ↗

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