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Abbott Molecular, Inc. Recall 89603

Description: Alinity m Integrated Reaction Units (IRU)

Abbott Molecular, Inc. Recall 89603 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0710-2022
Event ID89603
Event DescriptionAlinity m Integrated Reaction Units (IRU)
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, CO, CT, DC, FL, GA, IL, KY, LA, MA, MI, MO, NC, NJ, NY, OK, RI, SD, TX, WA, and WI.
Quantity3063 kits
Recall ReasonThere is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
Device Classification20220309
Device Code InfoList Number 09N26-010, Lot Numbers/UDI: 1) 766233 / (01)20884999047864(10)766233(11)210614(240)09N26-010 2) 770433 / (01)20884999047864(10)770433(11)210621(240)09N26-010 3) 771200 / (01)20884999047864(10)771200(11)210712(240)09N26-010 4) 771201 / (01)20884999047864(10)771201(11)210719(240)09N26-010 5) 773642 / (01)20884999047864(10)773642(11)210723(240)09N26-010
Center Classification Date20220302
Recall Initiation Date20220211
Recalling FirmAbbott Molecular, Inc.
Initial Notification Letter
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