Urgent Field Safety Notice For Architect I2000sr Analyzer By Abbott Laboratories

Abbott Laboratories has issued a Class I safety notice for ARCHITECT i2000SR Analyzer devices distributed in Germany and the EU. The notice addresses an urgent safety issue with these laboratory analyzers. This classification indicates a serious problem that could cause harm to patients or users.

Recalling firm
Abbott Laboratories
Product
ARCHITECT i2000SR Analyzer
Reason
Urgent Field Safety Notice for ARCHITECT i2000SR Analyzer by Abbott Laboratories
Classification
Class I
Category
medical device recall
Country
Germany
Agency
BFARM
Recall date
2026-10-20
Status
Ongoing
Distribution
Germany / EU

Official recall notice from BFARM

Recall details on Nibble Recalls: https://trynibble.app/recalls/4ecc8c55-8557-4cc5-bd8b-2ac9269b7e35