COBAS AMPLIPREP / COBAS TAQMAN HCV, US-IVD
Received Dec 1, 2011 · Event occurred Oct 5, 2011
Report 2243471-2010-00101 · MDR key 2354012
Device
Generic name
Assay, Hybridization, Nucleic Acid Amplification, Detection Of Hcv Rna
Manufacturer
Roche Molecular SystemsCatalog number
03568555190
Lot number
P03332
Product problems
- Low Test Results
Patient
Not reported
- No Information
Narrative
Description of Event or Problem
A CUSTOMER SITE IN (B)(6) FILED A COMPLAINT STATING THAT (B)(4) SURVEY SAMPLE HCV2-14 GENERATED A SLIGHTLY (B)(6) THAN EXPECTED HCV RESULT WHEN USING THE COBAS AMPLIPREP/ COBAS TAQMAN HCV TEST (M/N 03568555190; BATCH P03332). THE HCV TITER GENERATED WAS (B)(6) AND THE EXPECTED RANGE WAS (B)(6). THE RUN CONTROLS WERE VALID.
Additional Manufacturer Narrative
A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME, AS THE INVESTIGATION IS ONGOING. THE OUTCOME OF THE INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).