FDA recall Z-0641-2022

Microbiologics Inc · Class III · device

Product

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

Reason for recall

Some 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.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.

Key facts

Status
Terminated
Initiation date
2013-03-25
Report date
2022-02-23
Termination date
2022-04-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0641-2022