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 Problem
False Negative Result (1225)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.Device discarded, single use device.
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Event Description
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The consumer reported two (2) false negative results with the binaxnow covid-19 ag self-test for performed by her on (b)(6) 2022 and (b)(6) 2022.This mfr.Report addresses test two (2) of two (2).The customer reported a false negative result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022 on a nasal/throat kitted swab.Pcr confirmation testing was performed (platform: kaiser, sample type unknown) generated negative (ct values not provided) the consumer stated that she was symptomatic and experiencing cough, sleepy and sickness symptoms.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
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Manufacturer Narrative
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The required intake information to enable further investigation, such as the kit's lot number, was not provided and an lot-specific 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.H3 other text : device discarded, single use device.
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Event Description
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The consumer reported two (2) false negative results with the binaxnow covid-19 ag self-test for performed by her on (b)(6) 2022 and (b)(6) 2022.This mfr.Report addresses test two (2) of two (2).The customer reported a false negative result with the binaxnow covid-19 ag self-test performed on (b)(6) 2022 on a nasal/throat kitted swab.Pcr confirmation testing was performed (platform: (b)(6), sample type unknown).Generated negative (ct values not provided).The consumer stated that she was symptomatic and experiencing cough, sleepy and sickness symptoms.The customer confirmed there was no patient harm due to the test results.Additionally, the customer confirmed there was no delay or impact in the patient's treatment.
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Search Alerts/Recalls
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