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Microbiologics Inc Recall 89380

Description: KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.

Microbiologics Inc Recall 89380 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0544-2022
Event ID89380
Event DescriptionKWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Product TypeDevices
DistributionUS distribution to CA, FL, HI, MI, NC, NH, NJ, OK, OR, TN. International distribution to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, Vietnam.
Quantity47 packs (94 units)
Recall ReasonPotential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Device Classification20220209
Device Code InfoCatalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Center Classification Date20220131
Recall Initiation Date20210224
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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