COBAS AMPLICOR CHLAMYDIA TACHOMATIS TEST

Additional Manufacturer Narrative

(B)(4). NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATIONS.UPON INVESTIGATION THERE WAS NO TREND FOUND IN THE FIELD. QC RELEASE DATA FOR THE KIT BATCHES MET SPECIFICATIONS. NO INTERNAL NON-CONFORMANCES HAVE BEEN GENERATED FOR KIT BATCH P08563. NO PRODUCT OR BATCH NON-CONFORMANCE WAS IDENTIFIED. INVESTIGATIVE TESTING OF RETAIN KITS MET QC SPECIFICATIONS AND DID NOT REPRODUCE CUSTOMER'S ALLEGATION. ADDITIONALLY, THE CONTROLS FOR EACH CUSTOMER RUN WERE VALID. THE CUSTOMER WAS USING A NON-VALIDATED SAMPLE TYPE AND STATED THAT THEY WERE USING A 'MODIFIED' SAMPLE EXTRACTION PROCEDURE. AS ALL SAMPLES WERE EXTRACTED DURING THE MODIFIED EXTRACTION PROCEDURE AT THE CUSTOMER SITE, THIS TYPE OF DEVIATION FROM THE PACKAGE INSERT CAN AFFECT THE PERFORMANCE OF THE TEST. FOR RELIABLE TEST RESULTS, THE CUSTOMER SHOULD FOLLOW INSTRUCTIONS FOR PROPER SPECIMEN COLLECTION. THIS TEST IS NOT INTENDED FOR USE WITH THROAT, RECTAL, OR TYPES OF SPECIMENS OTHER THAN THOSE SPECIFIED.(B)(4).

Additional Manufacturer Narrative

A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION INTO THIS ISSUE IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).

Description of Event or Problem

A CUSTOMER SITE IN THE UNITED STATES ALLEGED THAT DISCREPANT RESULTS WERE GENERATED WITH THE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST. SPECIFICALLY, THE CUSTOMER STATED THAT THEY GENERATED A DISCREPANT RESULT FOR ONE PATIENT SAMPLE. THE CUSTOMER RE-RAN A (B)(6) SAMPLE (SAMPLE WAS ORIGINALLY TESTED WITH THE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST) ON A DIFFERENT COBAS AMPLICOR ANALYZER AND GENERATED A (B)(6) RESULT. THE CUSTOMER WAS USING OFF LABEL SAMPLE COLLECTION MEDIA. THE CONTROLS WERE VALID FOR BOTH RUNS.