ARCHITECT HBSAG QUALITATIVE II
Received Sep 28, 2012 · Event occurred Sep 3, 2012
Report 3008344661-2012-00055 · MDR key 2764926
Device
Product problems
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER STATED THAT A (B)(6) ARCHITECT HBSAG QUALITATIVE II RESULT OF (B)(6) WAS GENERATED FOR A DONOR PATIENT THAT TESTED (B)(6) DNA. THE SAMPLE RETESTED (B)(6) ON THE ARCHITECT ANALYZER. TESTING USING THE ORTHO VITROS HBSAG METHOD WAS (B)(6). TESTING USING THE ROCHE HBSAG METHOD WAS (B)(6). TESTING AT ANOTHER FACILITY USING THE ARCHITECT HBSAG ASSAY (LIST 06C36) WAS REPEATEDLY (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THIS REPORT IS BEING FILED ON INTERNATIONAL PRODUCT ARCHITECT HBSAG QUALITATIVE II, LIST NUMBER 2G22, THAT HAS A SIMILAR U.S. PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT HBSAG LIST NUMBER 1L80 AND ARCHITECT HBSAG QUALITATIVE, LIST NUMBER 4P53. (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.