INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN HOUSE WITH RETENTION PRODUCTS. RETENTION DEVICES WERE TESTED WITH COC AND THC +50% CUTOFF CONTROL AND 3X CUTOFF CONTROL. ALL COC AND THC RESULTS WERE POSITIVE AT READ TIME AND MET QC SPECIFICATIONS. NO FALSE NEGATIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.
D
Patient 1
THE CUSTOMER REPORTED A FALSE NEGATIVE COCAINE AND THC RESULT ON A PATIENT. AN ORAL FLUID SAMPLE WAS SENT TO THE LABORATORY AND PRODUCED A BENZOYLECGONINE (COCAINE) RESULT OF 63 NG/ML AND A THC RESULT OF 7 NG/ML. THE APPROPRIATE URINE SAMPLE TYPE WAS USED FOR THE MULTIDIP 8 DRUG TEST. HOWEVER, ORAL FLUID IS NOT INDICATED FOR THIS TEST. THEREFORE, A DIRECT COMPARISON BETWEEN THE RESULTS PROVIDED COULD NOT BE CONDUCTED. THERE WAS NO TREATMENT OR INTERVENTION ADMINISTERED BASED ON EITHER SET OF RESULTS. NO REPORTED ADVERSE PATIENT SEQUELA.