LetsGetChecked Inc.: Medical Device Recall in 2023 - (Recall #: Z-1212-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 16, 2022

Date Posted: March 15, 2023

Recall Number: Z-1212-2023

Event ID: 91611

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 50 units

Code Information:

(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024

Distribution Pattern:

US Nationwide distribution in the state of Alabama.

Voluntary or Mandated:

Voluntary: Firm initiated