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Open, Classified

KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P

FDA Recall Z-0984-2026 · Posted 2025-12-22

Recalling FirmMicrobiologics Inc
Recall StatusOpen, Classified
Product CodeJTR
Date Initiated2025-12-02
Product Quantity86 units (127 additional units 12/22/25)

Reason for Recall

Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.

Firm Action

An Urgent Medical Device Recall notification letter was sent to customers on 12/2/25. INSTRUCTIONS: 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 [email protected]. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. 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 An Urgent Medical Device Recall dated 12/22/25 was sent to customers. INSTRUCTIONS: 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 [email protected]. 5. KEEP this letter for your records. 6. NOTIFY other facilities or customers to whom the product may have been distributed or transferred. 7. 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 [email protected] with questions or concerns. Collect calls may be made.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide - US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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