| Catalog Number |
10336425 |
| Medical Device Problem Code |
False Positive Result (1227)
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| Health Effect - Clinical Code |
No Known Impact Or Consequence To Patient (2692)
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| Date of Event |
10/11/2016
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Additional Manufacturer Narrative
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The customer states she has prescribed antibiotics to patients with elevated results and has ordered further testing.The customer has received replacement strips and is fully operational on the new strips.
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Event or Problem Description
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The customer reported that some leukocyte results were incorrectly reported out due to deteriorated strips and patients were prescribed antibiotics that were not necessary.Specific data was not provided on these samples.
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Additional Manufacturer Narrative
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The reagent was returned for investigation.The investigation of the desiccants demonstrated that the strips were exposed to excessive moisture.Visual appearance of strips also consistent with moisture exposure.Per the multistix ifu: "protection against exposure to light, heat, and ambient moisture is mandatory to guard against altered reagent reactivity"."discoloration or darkening of the test pads may indicate deterioration." the customer is operational.
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Search Alerts/Recalls
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