LetsGetChecked Inc. Recall 91611
Description: LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
LetsGetChecked Inc. Recall 91611 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1212-2023 |
| Event ID | 91611 |
| Event Description | LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Alabama. |
| Quantity | 50 units |
| Recall 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. |
| Device Classification | 20230315 |
| Device Code Info | (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024 |
| Center Classification Date | 20230303 |
| Recall Initiation Date | 20220316 |
| Recalling Firm | LetsGetChecked Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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