Urgent Field Safety Notice For Rapidlab 348ex By Siemens Healthcare Diagnostics Inc. Tarrytown

Summary Siemens Healthcare Diagnostics is issuing an urgent field safety notice for the RapidLab 348EX laboratory analyzer. The notice affects devices distributed in Germany and the EU. This is classified as a Class I notice, indicating a serious issue that requires corrective action.

Recalling firm
Siemens Healthcare Diagnostics Inc. Tarrytown
Product
RapidLab 348EX
Reason
Urgent Field Safety Notice for RapidLab 348EX by Siemens Healthcare Diagnostics Inc. Tarrytown
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-06-03
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/6679ffcb-b9bc-4b47-bb94-7980ca6947cf