Catalog Number 11556712 |
Device Problem
False Negative Result (1225)
|
Patient Problem
Fever (1858)
|
Event Date 08/09/2022 |
Event Type
malfunction
|
Event Description
|
As holders of the emergency use authorization, siemens healthcare diagnostics is submitting this report on behalf of the manufacturer healgen scientific.The customer reported false negative result for covid on clinitest covid19 self test.There was no reported injury due to this event.
|
|
Manufacturer Narrative
|
Udi could not be included in this report since customer did not provide lot number.Event notified to healgen on (b)(6) 2022 was informed to siemens on (b)(6) 2022.Customer was vaccinated but had symptoms.The manufacturer requested more information from the customer to perform further investigation, however no response was received from the customer even after multiple attempts.The cause of this event is unknown.
|
|
Manufacturer Narrative
|
Siemens showed due diligence in attempting to obtain more information from the customer however, the customer has not responded.Without the lot information, further investigation is not possible.The cause of this event is unknown.
|
|
Search Alerts/Recalls
|