Reported Mar 15, 2023 · Ongoing
LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary…
LetsGetChecked Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LetsGetChecked Inc. · 1845 Steinway St · Astoria, NY · 11105-1010
Is this the product you have?
- LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
- Lot codes and dates
- (UDI): (01)00850024881341(17)240901(10)20391
- Lot Number20391 Exp
- Date01Sep2024
- Amount recalled
- 50 units
Where it was sold
- Nationwide
- AL
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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