ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW COVID-19 AG SELF TEST 2CT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
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Catalog Number 195-160 |
Device Problems
No Apparent Adverse Event (3189); Non Reproducible Results (4029)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event provided in section b3 is an approximation, was not provided by consumer.The intake information required to enable further investigation, such as the kit¿s lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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Event Description
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The consumer reported conflicting results with the binaxnow covid-19 antigen self-test performed on an unknown date.Per the consumer, the first test taken generated a positive result and the second test conducted and generated negative result.Confirmation testing was not performed.No additional patient information, including treatment and outcome, was provided.
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Event Description
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The consumer reported a positive result with the pcr at urgent care on (b)(6) 2023 and prescribed paxlovid as a result.The consumer proceeded with 2 binaxnow covid-19 antigen self-test performed on (b)(6) 2023 both generated positive results.Additionally, the consumer performed a third binaxnow covid-19 antigen self-test on (b)(6) 2024 and generated a negative result.No additional patient information, including treatment and outcome, was provided.
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Manufacturer Narrative
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Updated b5: customer provided additional information on 15apr2024 indicated that they performed one (1) pcr test and three (3) binaxnow tests.Abbott medical affair was consulted regarding the updated information, which provided that given the information that the patient tested negative after 3 days on paxlovid treatment, the negative results on (b)(6) 2024 is most likely truly reflecting the disease recovery progress rather than a false negative. date of event provided in section b3 is an approximation, was not provided by consumer.The intake information required to enable further investigation, such as the kit¿s lot number, was not provided and an investigation was not able to be performed.Notwithstanding, a review of complaints¿ trend reveals that all lots within expiry dating are performing according to the statements made in the package insert.In conclusion, abbott diagnostics scarborough was unable to determine the exact root cause of the reported issues as no information was provided for investigation.
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Search Alerts/Recalls
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