Recall Z-0543-2022
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, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.
Codes / lots: Catalog Number: 0726P, Lot Number: 726-57-10, UDI: 20845357017486
Reason for recall
Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.
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-0543-2022
- Initiated
- February 24, 2021
- Posted by FDA
- January 28, 2022
- Terminated
- July 11, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 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.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN