# FDA recall Z-1212-2023

> **LetsGetChecked Inc.** · Class II · device recall initiated 2022-03-16.

## 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.

## Distribution

US Nationwide distribution in the state of Alabama.

## Key facts

- **Recall number:** Z-1212-2023
- **Recalling firm:** LetsGetChecked Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-16
- **Report date:** 2023-03-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Astoria, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1212-2023

## Citation

> AI Analytics. FDA recall Z-1212-2023. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1212-2023. Source: US FDA. Licensed CC0.

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