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Abbott Ireland Limited Recall 92271

Description: Alinity i Anti-TPO Reagent Kit, List Number 09P3521

Abbott Ireland Limited Recall 92271 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1696-2023
Event ID92271
Event DescriptionAlinity i Anti-TPO Reagent Kit, List Number 09P3521
Product TypeDevices
DistributionUS Nationwide distribution in the states of CA, CO, FL, GA, IL, KY, LA, MD, MI, MN, NJ, NY, OH, RI, SC, SD, TN, TX, WA. No international distribution of affected lot.
Quantity110 kits
Recall ReasonDue to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Device Classification20230614
Device Code InfoUDI Number: (01)00380740153892(17)240720(10)46009FN00; List Number: 09P3521; Lot Number: 46009FN00; Expiration Date: 07/20/2024
Center Classification Date20230608
Recall Initiation Date20230424
Recalling FirmAbbott Ireland Limited
Initial Notification Letter
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