Product Safety Recalls

Product Recall Tracker

bioMerieux, Inc. Recall 88844

Description: API 50 CH, Model 50300

bioMerieux, Inc. Recall 88844 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0243-2022
Event ID88844
Event DescriptionAPI 50 CH, Model 50300
Product TypeDevices
DistributionDistribution in WI, NY, and SD
Quantity1382 kits
Recall ReasonThere is potential to provide an incorrect organism identification.
Device Classification20211124
Device Code InfoModel 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230
Center Classification Date20211117
Recall Initiation Date20210930
Recalling FirmbioMerieux, Inc.
Initial Notification Letter
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