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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
- Affected units
- 50
Distribution
Related recalls
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- ModerateIn2bones Recalls Partially Threaded Bone Screws Due to Labeling Error
FDA (Devices) · 2026-10-21
- SevereInstrumentation Laboratory Recalls HemoslL AcuStar HIT-lgG In Vitro Diagnostic Reagents
FDA (Devices) · 2026-10-21
- SevereDeano's Pasta Recalls Pear and Pecorino Ravioli for Undeclared Lobster
FDA (Food) · 2026-10-21
Similar recalls
- LowBiochemical Diagnostics Recalls hCG Control Kits Due to Labeling Discrepancies
FDA (Devices) · 2015-12-02
- LowPerkinElmer 226 Sample Collection Device Recalled for Labeling Mismatch
FDA (Devices) · 2017-08-02
- ModerateMedline Blood Culture Collection Kits Recalled for Incorrect Expiration Dates
FDA (Devices) · 2022-11-02
- ModerateBioMerieux BacT/ALERT Combo Modules Recalled for Software Mislabeling
FDA (Devices) · 2012-11-28
- LowMagellan LeadCare II Blood Lead Test Kit Recall for Labeling Error
FDA (Devices) · 2026-10-21
- HighVITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results
FDA (Devices) · 2023-05-31