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Microbiologics Inc Recall 89513

Description: LYFO Disk

Microbiologics Inc Recall 89513 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0788-2022
Event ID89513
Event DescriptionLYFO Disk
Product TypeDevices
DistributionDistribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Quantity3 units
Recall ReasonLYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
Device Classification20220323
Device Code InfoCatalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Center Classification Date20220316
Recall Initiation Date20150717
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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