Class 2 Device Recall LetsGetChecked Blood Sample Collection Kit

• Date Initiated by Firm: March 16, 2022
• Date Posted: March 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1212-2023
• Recall Event ID: 91611
• Product Classification: Blood specimen collection convenience kit (excludes HIV) - Product Code PQD
• Product: LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
• Code Information: (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
• Recalling Firm/ Manufacturer: LetsGetChecked Inc.; 1845 Steinway St; Astoria NY 11105-1010
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.