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

FDA device recall Z-0876-2026 · posted 2025-12-02 · Open, Classified

Recall details

Recalling firm

Microbiologics Inc

Reason for recall

Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JTR

Quantity affected

5 units

Distribution

International distribution to the countries of UAE, China, Singapore, Kazakhstan,

Date initiated

2025-11-13

Date posted

2025-12-02

Location

Saint Cloud, MN