KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
- Company
- Microbiologics Inc
- Recall Initiated
- February 24, 2021
- Posted
- January 31, 2022
- Terminated
- July 11, 2022
- Recall Number
- Z-0544-2022
- Quantity
- 47 packs (94 units)
- Firm Location
- Saint Cloud, MN
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.
Lot / Code Info
Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Root Cause
Labeling mix-ups
Action Taken
Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3.COMPLETE the response form provided; 4. RETURN the response form to recall@microbiologics.com; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or recall@microbiologics.com.