PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: February 9, 2022 Initiated: February 24, 2021 #Z-0543-2022

Product Description

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.

Details

Recalling Firm
Microbiologics Inc
Units Affected
65 packs (130 units)
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.
Location
Saint Cloud, MN

Frequently Asked Questions

What product was recalled?
KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.. Recalled by Microbiologics Inc. Units affected: 65 packs (130 units).
Why was this product recalled?
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 9, 2022. Severity: Low. Recall number: Z-0543-2022.