Catalog Number 195-000 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Blurred Vision (2137); Burning Sensation (2146)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.A supplemental report will be provided after completion.
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Event Description
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The user reported accidentally using the reagent as eyedrops.The user was advised to immediately flush eyes with water for 15 minutes.No additional information was provided.
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Manufacturer Narrative
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Corrected data : b5, g3, e3, h2.
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Event Description
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The user reported accidentally using the reagent as eyedrops.Per user, eye was irritated.The user was advised to immediately flush eyes with water for 15 minutes.
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Manufacturer Narrative
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This supplemental report is being submitted to provide the investigation conclusion.Technical service provided the safety data sheet to the customer.According to the package insert in195000 v 3.0 precautions the extraction reagent packaged in this kit contains saline, detergents and preservations that will inactivate cells and virus particles.Samples eluted in this solution are not suitable for culture.The product will continue to be monitored and tracked.
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Search Alerts/Recalls
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