I-STAT ANALYZER

Description of Event or Problem

A REMEDIAL ACTION HAS BEEN INITIATED TO PROVIDE RECOMMENDATIONS TO THE CUSTOMER FOR PRODUCT IN THE FIELD. THE I-STAT SYSTEM IS INTENDED FOR USE WITH I-STAT CARTRIDGES FOR IN VITRO QUANTIFICATION OF VARIOUS ANALYTES IN WHOLE BLOOD OR PLASMA SAMPLES. THE I-STAT ANALYZERS (HANDHELDS) ARE POWERED BY TWO 9-VOLT BATTERIES, EITHER DISPOSABLE OR RECHARGEABLE. ABBOTT POINT OF CARE HAS DETERMINED THAT SOME I-STAT ANALYZERS HAVE THE POTENTIAL TO BECOME UNCOMFORTABLY HOT TO TOUCH IN THE AREA OF THE BATTERY COMPARTMENT. OUR INVESTIGATION HAVE DETERMINED THAT THE BATTERIES CAN BECOME OVERHEATED DUE TO A COMPONENT FAILURE WITHIN THE ANALYZER CIRCUITRY. THERE HAVE BEEN NO REPORTS OF INJURY ASSOCIATED WITH THIS ISSUE. ABBOTT POINT OF CARE HAS MADE THE DECISION TO SEND THIS NOTIFICATION TO ENSURE THE SAFETY OF OUR CUSTOMERS. THIS ACTION IS BEING CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION AND HEALTH (B)(4).

Additional Manufacturer Narrative

ISTAT1 ANALYZER - (B)(4). ALSO INCLUDED IN FIELD ACTION: I-STAT PORTABLE CLINICAL ANALYZER (B)(4). FUSO ANALYZER (B)(4), I-STAT1 ABAXIS ANALYZER (B)(4), MILITARY KIT ISTAT1 (B)(4)001, MILITARY KIT PORTABLE CLINICAL ANALYZER (B)(4). DETAILS WILL BE PROVIDED WITH THE ACTION THAT WILL BE CONDUCTED IN COOPERATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION.