KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling KWIK-STIK Enterobacter cloacae subsp. cloacae products (Catalog Number 0323P, Lot Number 323-108-7) because units from lot 323-108-7 were packaged in pouches labeled as a different product (726-57-10). The recall affects 47 packs containing 94 total units of these in vitro diagnostic controls that were distributed across the United States (California, Florida, Hawaii, Michigan, North Carolina, New Hampshire, New Jersey, Oklahoma, Oregon, and Tennessee) and internationally to Canada, Ecuador, France, India, Indonesia, Ireland, Japan, Mexico, South Africa, United Arab Emirates, and Vietnam.
The source record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
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. Quantity: 47 packs (94 units) Lot/code info: Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.