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Catalog Number PRD-06419 |
Device Problem
Device Contaminated at the User Facility (4064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Event Description
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Customer reported positive contamination on two of their panther instruments, panther fusion sn (b)(4) and panther sn (b)(4), during monthly environmental swab testing.Swabs which should have resulted negative had low positive results instead, indicative of instrument contamination.Customer stated their panther instruments were used for sars-cov-2 testing but did not specify which sars-cov-2 assay was used/affected at this time.Hologic contacted customer multiple times but could not reach them to obtain further information such as affected assay lots, worklists, or sample ids.The information provided by the customer was insufficient to characterize any sample as a confirmed false result.Hologic confirmed that customer did not report out positive results during the affected period without confirming their validity on another platform.There were no associated/reported adverse events or patient impact reported.
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Manufacturer Narrative
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Customer performed a deep-clean monthly maintenance, including sample shields, racks, reagent and sample preparation areas, but issue persisted.Customer performed a second decontamination, which resolved the issue and generated valid results.Hologic technical support and applications specialists attempted to obtain more information multiple times from customer, but they were unresponsive.No further investigation or troubleshooting could be completed, but no further issues were reported.As part of eua agreement, fda requires all aptima sars-cov-2 assay questioning results and false results (confirmed or not) complaints to be reported as malfunction mdr.Device evaluated by mfr: other.
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Search Alerts/Recalls
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