The issue was initially reported by the distributor.On (b)(6) 2018, the patient arrived at the facility with a sore throat, body aches, fever, and cough that had been occurring for one week.The patient also had a red throat and large lymph nodes.The patient was tested with a medline strep a test strip using a dual swab technique and a negative strep a result was obtained.The customer stated a bactiswab was used for the test instead of the kitted medline strep a test strip swab.The customer stated the swab used was sterile but was unable to confirm if rayon transport swabs containing modified stuart's or amies liquid medium were used.A confirmatory culture was also performed using a bactiswab and later produced a positive strep a result (the date of the strep a culture result could not be provided per the customer).On (b)(6) 2018, the patient reported feeling dizzy.The patient was prescribed 500 mg of penicillin vk, 2x/day for 10 days based off the positive culture report.Per the customer, although the patient was delayed in receiving treatment due to the medline strep a test strip result, no adverse patient outcome occurred.Troubleshooting was conducted with the customer.The customer was advised to use validated swabs (rayon transport swabs containing modified stuart's or amies liquid medium).Furthermore it was recommended that a single swab method be employed when using a medline strep a test strip test.
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