Medical device recalls

Microbiologics Inc recalls KWIK-STIK(TM), Quality control kit for culture media, sold as: KWIK-STIK(TM) 2-pack Enterococcus faecalis derived from…

Recall date
March 25, 2013
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0641-2022
FDA classification
Class III
Brand / firm
Microbiologics Inc
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada, South Africa, France, Netherlands, Mauritius, China.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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

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