Z-1212-2023Class II

LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the...

Name: Z-1212-2023 LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the...
Creator: LetsGetChecked Inc.
Published: 2022-03-16
License: https://open.fda.gov/license/

LetsGetChecked Inc / initiated 2022-03-16 / Open, Classified / root cause: packaging

FDA source

LetsGetChecked Inc. began a recall of LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood... on 2022-03-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1212-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-16
Posted: 2023-03-03
Recalling firm: LetsGetChecked Inc
Product: LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Product code: PQD Blood Specimen Collection Convenience Kit (Excludes Hiv)
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 50 units
Distribution: US Nationwide distribution in the state of Alabama.
Product codes and lots: (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1212-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1212-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-03

Product code PQD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)