REACTIFS NIT1+ NIT2

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

CUSTOMER REPORTED RECEIVING A REACTIFS NIT 1+NIT 2 4AMP KIT, REF 70442, LOT 1003973730, EXPIRATION DATE 09 APR 2016 WITH INCORRECT LABELS. NORMALLY THE KIT HAS 4 EMPTY BOTTLES (2 WITH THE LABEL NIT 1, TWO WITH THE LABEL NIT 2). IN THIS KIT THE CUSTOMER FOUND 4 BOTTLES WITH THE NIT 1 LABEL. CUSTOMER IDENTIFIED THE DISCREPANCY PRIOR TO USE AND CHANGED THE LABELS. THE CUSTOMER CONFIRMS NO ERRONEOUS PATIENT RESULTS WERE COMMUNICATED TO THE CLINICIAN. THERE WAS NO DELAY BECAUSE CUSTOMER CORRECTED THE LABEL IMMEDIATELY BEFORE DECANTING THE PRODUCT.

Additional Manufacturer Narrative

INTERNAL INVESTIGATION WAS CONDUCTED. NO PHOTOS WERE PROVIDED BY THE CUSTOMER. REVIEW OF MANUFACTURING QC RECORDS INDICATES THE LOT PASSED ON INSPECTION. THE BOTTLES (4) WITHIN THE IDENTIFIED KIT ARE EMPTY BOTTLES, TWO ARE TO BE LABELED NIT1 AND TWO ARE TO BE LABELED NIT2. THERE IS NO POSSIBILITY OF ADVERSE IMPACT TO A PATIENT AS A RESULT OF THE LABEL DISCREPANCY. THE DISCREPANCY WAS IMMEDIATELY NOTICEABLE TO THE USER, AND LABEL CORRECTION WAS PERFORMED AT THE CUSTOMER'S DISCRETION AS ALL FOUR BOTTLES ARE IDENTICAL (EMPTY) OTHER THAN THE LABEL. ADDITIONAL TRAINING WAS CONDUCTED FOR THE PRODUCTION TEAM TO ENSURE A SIMILAR ISSUE DOES NOT RECUR.