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Universal Meditech Inc. Recall 92659

Description: PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS

Universal Meditech Inc. Recall 92659 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0055-2024
Event ID92659
Event DescriptionPrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Product TypeDevices
DistributionU.S.: CA, FL, IL, LA, NJ, NY, TX and WY O.U.S.: Taiwan
QuantityUnknown
Recall ReasonUniversal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS┬┐ SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.
Device Classification20231101
Device Code InfoModel Number: 100-17 UDI-DI Code: None Lot Numbers: All products manufactured after March 2021
Center Classification Date20231023
Recall Initiation Date20230522
Recalling FirmUniversal Meditech Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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