Recall Z-0544-2022
Microbiologics Inc · initiated February 24, 2021
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
KWIK-STIK, Enterobacter cloacae subsp. cloacae derived from ATCC 13047, REF 0323P. Packaged 2 units per pack. IVD controls.
Codes / lots: Catalog Number: 0323P, Lot Number: 323-108-7, UDI: 20845357006381
Reason for recall
Potential of products packaged for lot 323-108-7 were packaged in pouches labeled as 726-57-10.
FDA-determined 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.
Details
- Recall number
- Z-0544-2022
- Initiated
- February 24, 2021
- Posted by FDA
- January 31, 2022
- Terminated
- July 11, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN