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Recall Observatory FDA recall evidence

Device product

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

Z-1212-2023

March 16, 2022

Class II

Product summary

Firm
LetsGetChecked Inc.
Event
Event 91611
Status
Ongoing
Classification
Class II
Quantity
50 units
Official record key
device-enforcement:Z-1212-2023

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.