Model Number STRIP, WALGREENSKETONE 50CT #496636 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Ketone test strips were returned - defect was detected.Root cause: rc-061: storage outside specifications.Note: manufacturer contacted customer in a follow-up call on 18-jan-2021 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated that is comfortable with the results new replacement products.
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Event Description
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Consumer reported complaint for discoloration of ketone strips.Customer stated that the pads on the ketone strips are color grey.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The ketone test strip lot manufacturer¿s expiration date is 10/18/2021 and open vial date is undisclosed.
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Search Alerts/Recalls
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