Blood Sample Collection Kits Shipped With Incorrect Identification Labels
LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving incorrect sample identification due to mislabeled shipping labels. While no illnesses or injuries have been reported, the potential for incorrect Hepatitis C Virus diagnostic results and delayed medical care represents a risk of clinical harm where injury has not yet been reported.
Plain-English summary
LetsGetChecked Inc. is recalling Blood Sample Collection kits (Lot 20391, expiration 01 Sep 2024). These are in vitro diagnostic medical devices intended for primary containment and preservation of blood samples.
Some collection kits were distributed with incorrect shipping labels. Users received sample collection kits that were assigned to other users, resulting in a mismatch between the user identification on the kit and the person who received it.
Affected users may receive incorrect Hepatitis C Virus (HCV) test results, or their samples may be rejected due to mismatched demographic information, potentially delaying testing and treatment. Consumers who may have received an affected kit or already submitted a sample should contact LetsGetChecked Inc. or their healthcare provider for further guidance.
The recalled product
- Product
- LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
- Manufacturer
- LetsGetChecked Inc.
- Hazard
- mis-labeling
- identification-mismatch
- diagnostic-error
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03