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Abbott Point of Care issues safety action on I-Stat hs-TnI cartridge for labs
France's medicines safety agency, ANSM, has been notified of a safety action by Abbott Point of Care concerning the I-Stat hs-TnI cartridge, a test cartridge used in clinical biochemistry. The action is registered under reference R2630991 and is aimed at medical biology laboratories. Affected users were sent a letter from the company dated 29 October 2026, and the notice itself does not give details beyond that letter.
What does it mean?
Laboratories that use this Abbott test cartridge to measure troponin, a heart-related marker, have been told about a safety problem. The details are in the letter sent to users, so labs need to read that letter.