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Gentueri Inc Recall 89336

Description: Gentueri Viral Transport Medium Kit with 8cm Breakpoint Swab

Gentueri Inc Recall 89336 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0561-2022
Event ID89336
Event DescriptionGentueri Viral Transport Medium Kit with 8cm Breakpoint Swab
Product TypeDevices
DistributionDomestic: Illinois, Nebraska, and Wisconsin.
Quantity13,975 units (2 mL in a 15 mL conical tube)
Recall ReasonKits failed sterility testing and showed evidence of contamination.
Device Classification20220216
Device Code InfoCAT#: 3300-000; Lot No.: 1029.
Center Classification Date20220204
Recall Initiation Date20200706
Recalling FirmGentueri Inc
Initial Notification E-Mail
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