ClearanceBrief
Recall Z-0876-2026 ยท JTR Kit, Quality Control For Culture Media

Microbiologics Inc

KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K

DateDec 2, 2025 (initiated Nov 13, 2025)
StatusOpen, Classified
ReasonSome products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Root causeUnder Investigation by firm
ActionAn 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
Quantity5 units
DistributionInternational distribution to the countries of UAE, China, Singapore, Kazakhstan,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.