ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG COBAS MPX TEST, CE-IVD; ASSAY, HYB AND/OR NUCLEIC ACID AMP FOR DETECTION OF HCV RNA, HIV RNA
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Catalog Number 06997708190 |
Device Problems
False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be submitted upon completion of the investigation.(b)(4).
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Event Description
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A customer in the united (b)(6) alleged a false non-reactive hcv results for a serology-positive sample when tested with the cobas 6800 mpx test (lot g01162).The blood was not released and no harm or injury was alleged.
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Manufacturer Narrative
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No issues were identified with the complaint kit lot during the course of the investigation.Additionally, viral load testing was performed on two aliquots from the alleged donor sample to determine the viral load for hcv, using the abbott realtime hcv viral load test.Testing was performed by a third party external lab.The results for both aliquots of the donor sample with the abbot realtime viral load hcv assay were target not detected.No definitive conclusions can be drawn from the abbott realtime hcv viral load test results as the samples were received thawed prior to testing at the third party external lab.(b)(4).
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Search Alerts/Recalls
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