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LetsGetChecked Inc. Recall 91611

Description: LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.

LetsGetChecked Inc. Recall 91611 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1212-2023
Event ID91611
Event DescriptionLetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
Product TypeDevices
DistributionUS Nationwide distribution in the state of Alabama.
Quantity50 units
Recall ReasonUsers 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.
Device Classification20230315
Device Code Info(UDI): (01)00850024881341(17)240901(10)20391 Lot Number: 20391 Exp. Date: 01Sep2024
Center Classification Date20230303
Recall Initiation Date20220316
Recalling FirmLetsGetChecked Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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