Recall Z-1212-2023— LetsGetChecked Inc.
Class II · Ongoing
Class II FDA medical device recall by LetsGetChecked Inc., initiated 2022-03-16. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- LetsGetChecked Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-16
- Firm location
- Astoria, NY, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.