FDA recall Z-0543-2022

Product

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

Reason for recall

Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

Distribution

Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.

Key facts

Status

Terminated

Initiation date

2021-02-24

Report date

2022-02-09

Termination date

2022-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0543-2022