Recall Z-0581-2022
Microbiologics Inc · initiated October 8, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
KWIK-STIK(TM) 2 Pack Clostridium perfringens derived from ATCC(R) 13124(TM)
Codes / lots: Catalog Number : 0318P, Lot Number: 318-234-4, UDI: 20845357006213
Reason for recall
The incorrect lot number was printed on the foil pouch that the KWIK-STIK" is placed in. All foil pouches for lot 318-234-4 have the lot number misprinted as 218-234-4. The correct lot number was printed on the KWIK-STIK" canister label and KWIK-STIK" device label.
FDA-determined cause: Employee error
Action taken
Microbiologics notified customers on about 10/08/2020 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions included the following: 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 orrecall@microbiologics.com.
Details
- Recall number
- Z-0581-2022
- Initiated
- October 8, 2020
- Terminated
- July 7, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 187 units
- Distribution
- US distribution to . International distribution to Austria, Botswana, Brazil, Canada, China, Colombia, Finland, France, Germany, Guatemala, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Lithuania, Malaysia, Mauritius, Netherlands, Norway, Oman, Peru, Poland, Romania, South Africa, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Vietnam
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN