FDA Device recall Z-1212-2023
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preserv…
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preserv… by Letsgetchecked, citing 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 sa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1212-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-16 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Letsgetchecked |
| Distribution | US |
Product
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
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.
Identifiers
| code_info | (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1212-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.