LetsGetChecked Blood Sample Collection kit-In vitro recall
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of…
Why was LetsGetChecked Blood Sample Collection kit-In vitro recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
- Product
- LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of…
- Recalling firm
- LetsGetChecked Inc.
- Quantity
- 50 units
- Distribution
- US Nationwide distribution in the state of Alabama.
- Recall date
- March 15, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)