LetsGetChecked Blood Sample Kit (LetsGetChecked) – Mislabeled Samples (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Brand
LetsGetChecked Inc.
Lot Codes / Batch Numbers
(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
Products Sold
(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
LetsGetChecked Inc. is recalling LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended due to Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result,. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026