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Microbiologics Inc Recall 90761

Description: Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N

Microbiologics Inc Recall 90761 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1740-2022
Event ID90761
Event DescriptionHelix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
Product TypeDevices
DistributionInternational distribution to the country of United Kingdom.
Quantity2
Recall ReasonProduct not registered for use in the UK
Device Classification20220921
Device Code Infoa. UDI Number: 10845357043846, Lot Number: HE0071-01-1, Expiration Date: 12/31/2022. b. UDI Number: 10845357043945, Lot Number: HE0073-02-2, Expiration Date: 02/28/2023.
Center Classification Date20220916
Recall Initiation Date20220727
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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