LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary cont
Summary
The FDA issued a Class II for LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device sp by LetsGetChecked Inc.. Reason: Users received sample collection kits that were assigned to another user. Incorrect shipping labels were applied to the collection kits. As a result,.
Details
Source
Device Recall
External ID
Z-1212-2023
Action Date
2023-03-15
Status
Ongoing
Category
device
Product Description
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Lot/Code Info: (UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
Quantity Affected: 50 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-03-16
Company
Astoria, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 137 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (LetsGetChecked Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does LetsGetChecked Inc. have FDA actions?
This is the only FDA action we have on record for LetsGetChecked Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1212-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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