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American Contract Systems, Inc. Recall 90324

Description: Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A

American Contract Systems, Inc. Recall 90324 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1277-2022
Event ID90324
Event DescriptionNasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
Product TypeDevices
DistributionUS distribution in the state of Minnesota.
Quantity274,400 kits total
Recall ReasonAffected products were assembled off-site by individuals who may not have been properly trained.
Device Classification20220713
Device Code InfoUDI-DI: 00191072121233 Lots: 721211, 672211, 657211, 994221, 980221, 974221
Center Classification Date20220701
Recall Initiation Date20220502
Recalling FirmAmerican Contract Systems, Inc.
Initial Notification Letter
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