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OXFORD IMMUNOTEC LTD Recall 90654

Description: T-Cell Xtend REF TTK.610 US

OXFORD IMMUNOTEC LTD Recall 90654 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1642-2022
Event ID90654
Event DescriptionT-Cell Xtend REF TTK.610 US
Product TypeDevices
DistributionU.S.: AL, CA, DC, GA, IN, OR, and WA O.U.S.: None
Quantity47 units
Recall ReasonDue to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the validated storage time.
Device Classification20220907
Device Code InfoModel/Catalog Number: TTK.610 US UDI-DI Code: 15051716000022 Lot Number: 1001
Center Classification Date20220826
Recall Initiation Date20220707
Recalling FirmOXFORD IMMUNOTEC LTD
Initial Notification Letter
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