LetsGetChecked Blood Sample Collection kit-In vitro diagnostic… — Class II medical device recall Z-1212-2023
Ongoing recall by LetsGetChecked Inc., reported 2023-03-15, distributed nationwide. Users received sample collection kits that were assigned to another user. Incorrect shipping labels were appli
| Recall number | Z-1212-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LetsGetChecked Inc., Astoria, NY, United States |
| Recall initiated | 2022-03-16 |
| Classified | 2023-03-03 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 50 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00850024881341 |
| Lot numbers | 20391 |
| Expiration dates | 2024-09-01 |
Product
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1212-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.