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Microbiologics Inc Recall 89479

Description: KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)

Microbiologics Inc Recall 89479 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0641-2022
Event ID89479
Event DescriptionKWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from ATCC(R) 51299(TM)
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.
Quantity10 units
Recall ReasonSome of the KWIK-STIK Catalog #01023P Campylobacter coli, Lot# 1023-05-7, contained an inner label stating the product is Catalog #0919K Haemophilus influenza. The organism has been confirmed to be C. coli, indicating this is a labeling error and the organism is the correct organism.
Device Classification20220223
Device Code InfoCatalog Number 01023P, UDI: 20845357029502, Lot Number (Expiration Date): 1023-05-7 (04/30/2014)
Center Classification Date20220214
Recall Initiation Date20130325
Recalling FirmMicrobiologics Inc
Initial Notification Letter
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