A CUSTOMER REPORTED TO BIOM?RIEUX A DISCREPANT RESULT ON THE VIDAS VZG TEST KIT. THE SAMPLE WAS COLLECTED FROM A PREGNANT WOMAN AND GAVE A NEGATIVE RESULT WHEN TESTED WITH THE VIDAS VZG KIT. THE SAMPLE WAS SENT TO THE LEEDS REFERENCE LABORATORY AND RETURNED A POSITIVE RESULT. THE PATIENT DID NOT RECEIVE ANY TREATMENT. THE TREATMENT DECISION WAS BASED ON THE REFERENCE LABORATORY TEST RESULTS. VIDAS VARICELLA-ZOSTER IGG (VZG) IS AN AUTOMATED QUALITATIVE TEST FOR USE ON THE INSTRUMENTS OF THE VIDAS FAMILY, FOR THE DETECTION OF IGG ANTIBODIES TO VARICELLA ZOSTER VIRUS IN HUMAN SERUM USING THE ELFA (ENZYME LINKED FLUORESCENT ASSAY) TECHNIQUE. VIDAS VZG IS INTENDED AS AN AID IN THE DETERMINATION OF IMMUNOLOGICAL EXPERIENCE WITH VARICELLA ZOSTER VIRUS. AN INTERNAL INVESTIGATION HAS BEEN INITIATED WITHIN BIOM?RIEUX.
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Patient 1
10 POSITIVE OR EQUIVOCAL NEAR POSITIVITY SAMPLES WERE TESTED ON RETAIN SAMPLES FROM LOT 1003778670. THE 10 SAMPLES GAVE APPROPRIATE RESULTS AND ARE WITHIN SPECIFICATION. COMPARED TO THE QUALITY CONTROL RESULTS OBTAINED DURING LOT RELEASE, LOT 1003778670 HAS NOT CHANGED. IN CONCLUSION, THE INVESTIGATION SHOWED THAT THERE IS NO QUALITY DRIFT FOR LOT 1003778670 AND IS WITHIN PERFORMANCE SPECIFICATIONS AS DEFINED WITHIN THE PACKAGE INSERT.