I-STAT CG4+ CARTRIDGE

Description of Event or Problem

ABBOTT HAS RECEIVED AN UPDATED (U.S.) FDA 510(K) CLEARANCE FOR THE I-STAT CG4+ CARTRIDGE (WHITE). THE I-STAT CG4+ CARTRIDGE WITH THE I-STAT 1 SYSTEM IS INTENDED FOR USE IN THE IN VITRO QUANTIFICATION OF PH, PARTIAL PRESSURE OF OXYGEN (PO2), PARTIAL PRESSURE OF CARBON DIOXIDE (PCO2) AND LACTATE. IN ADDITION, THE I-STAT CG4+ CARTRIDGE PROVIDES CALCULATED VALUES FOR TCO2, HCO3, BASE EXCESS (BE) AND SATURATED OXYGEN (SO2). ABBOTT HAS RECEIVED AN UPDATED U.S. FDA 510(K) CLEARANCE FOR THE I-STAT CG4+ CARTRIDGE FOR USE WITH ARTERIAL AND VENOUS WHOLE BLOOD SAMPLES FOR LACTATE AND FOR ARTERIAL, VENOUS, AND CAPILLARY WHOLE BLOOD SAMPLES FOR PH, PCO2 AND PO2. THIS UPDATED 510(K) CLEARANCE APPLIES TO ALL I-STAT CG4+ CARTRIDGES (WHITE) THAT YOU MAY ALREADY HAVE ON HAND. CURRENTLY, THE I-STAT CG4+ CARTRIDGES (03P85-25) ARE NOT FDA CLEARED FOR THE MEASUREMENT OF LACTATE IN CAPILLARY WHOLE BLOOD SAMPLES. ABBOTT HAS SUBMITTED THIS COMMUNICATION REGARDING THE PRODUCT UPDATES TO THE U.S. FOOD AND DRUG ADMINISTRATION. ABBOTT HAS NOT RECEIVED REPORTS OF PATIENT HARM ASSOCIATED WITH THE USE OF THE I-STAT CG4+ CARTRIDGES. RISK TO HEALTH ABBOTT DOES NOT CURRENTLY HAVE THE DATA NECESSARY TO DEMONSTRATE PERFORMANCE WITH CAPILLARY WHOLE BLOOD FOR THE LACTATE TEST. DUE TO THE RISKS POSED BY INACCURATE LACTATE RESULTS, CAPILLARY WHOLE BLOOD SAMPLES ARE NOT SUITABLE FOR TESTING LACTATE.

Additional Manufacturer Narrative

RECALL SUBMISSION TO FDA: APOC2025-003. FDA EVENT: RES# 97442.