Recall Z-0876-2026
Microbiologics Inc · initiated November 13, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Codes / lots: UDI-DI: 30845357020018; Lot Number: 818-111-7
Reason for recall
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA-determined cause: Under Investigation by firm
Action taken
An Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to recall@microbiologics.com. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.
Details
- Recall number
- Z-0876-2026
- Initiated
- November 13, 2025
- Posted by FDA
- December 2, 2025
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 5 units
- Distribution
- International distribution to the countries of UAE, China, Singapore, Kazakhstan,
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN