PlainRecalls
FDA Devices Low Class III Terminated

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

Reported: February 9, 2022 Initiated: February 24, 2021 #Z-0544-2022

Product Description

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.

Details

Recalling Firm
Microbiologics Inc
Units Affected
47 packs (94 units)
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.
Location
Saint Cloud, MN

Frequently Asked Questions

What product was recalled?
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.. Recalled by Microbiologics Inc. Units affected: 47 packs (94 units).
Why was this product recalled?
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 9, 2022. Severity: Low. Recall number: Z-0544-2022.