LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Check against the official notice below — it lists the full affected range.
LetsGetChecked Inc. is recalling 50 Blood Sample Collection kits distributed nationwide in Alabama due to incorrect shipping labels that caused users to receive kits assigned to different users. This mismatch of user identification creates the risk that users may return samples and receive incorrect Hepatitis C Virus (HCV) test results, or their samples may be rejected due to mismatched demographic information, potentially resulting in delayed testing and treatment.
The affected kits have lot number 20391 with an expiration date of September 1, 2024, and were identified by UDI (01)00850024881341(17)240901(10)20391. The recall notice does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: US Nationwide distribution in the state of Alabama. Quantity: 50 units Lot/code info: (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.