LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result, a number of users received sample collection kits that were assigned to another user resulting in a mismatch of user identification. The impact to users is that they may return the sample and obtain potential incorrect Hepatitis C Virus (HCV) results and/or the sample may be rejected due to mismatched demographics resulting in delayed testing and/or treatment.

LetsGetChecked initiated recall via telephone on 3/16/22 and letters where appropriate. Telephone contact described reason for recall and identification of the name and kit number: If all information is correct for the member and matches in Core, then there is no issue, and a replacement test does not need to be offered. If any information is incorrect for the member and does not match the registration in Core, confirm if the member has an upcoming HouseCalls visit, document that member needs a replacement on the tracking spreadsheet and a replacement test will be sent via expedited shipping.