PTS PANELS GLUCOSE TEST STRIPS

Description of Event or Problem

A CUSTOMER REPORTED HAVING IN THEIR POSSESSION A VIAL OF PTS PANELS/CARDIOCHEK GLUCOSE STRIPS WHICH HAD A PRIMARY (IMMEDIATE) VIAL LABEL OF LOT (B)(4), EXPIRATION DATE 2010-01-14 AND AN OUTER BOX LABEL OF P821, EXPIRATION DATE 2009-08-20. THE LOT NUMBER ON THE PRIMARY VIAL BEARING THE U (B)(4) IS THE CORRECT CITATION FOR A CARDIOCHEK GLUCOSE MATERIAL. THE MEMO CHIP CONTAINED WITHIN THE BOX, WHICH PROVIDES THE SPECIFIC ANALYTE CONVERSION CURVE (FROM THE INSTRUMENT REFLECTANCE READING) WHICH THE CARDIOCHEK USES TO DISPLAY THE RESULT OF A TEST WAS THE CORRECT (B)(4) MEMO CHIP. AN INTERNAL INVESTIGATION DEMONSTRATED A LIKELY VERY LOW INCIDENCE OF THIS MISLABELED PRODUCT. THE PRIMARY LABEL IS CORRECT AND THE MEMO CHIP WHICH DICTATES GLUCOSE RESULTS DISPLAY WAS CORRECT. THUS THERE IS NO ADVERSE USER CONSEQUENCE RESULTING FROM THE MISLABELING AND THERE IS NO MEDICAL OR HEALTH RISK. FURTHERMORE, THE PRODUCT IMPACT IS THAT AFTER (B)(6) 2009, THE OUTSIDE LABEL WOULD LEAD THE USER TO THINK THE PRODUCT WAS OUT OF DATE WHEN INDEED IT REMAINED WITHIN EXPIRATION DATE. THIS MEDWATCH IS BEING REPORTED TO ALERT POTENTIAL USERS OF THIS MISLABELING WHICH HAS NO PERFORMANCE IMPACT OR ADVERSE HEALTH EFFECT.