FDA recall Z-0544-2022

Product

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

Reason for recall

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

Distribution

US 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.

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-0544-2022