LetsGetChecked product recalled over hepatitis A risk

Recall date

March 16, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

LetsGetChecked Inc. recalls LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary con…

Recall number

Z-1212-2023

FDA classification

Class II

Brand / firm

LetsGetChecked Inc.

Sold / distributed

US Nationwide distribution in the state of Alabama.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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