Microbiologics Inc recalls KWIK-STIK 6-Pack
Reason for recall
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Lot / code information
- UDI
- 30845357006463
- Lot #
- 325-120-1, 325-120-4, 325-120-6, Additional Lots added 12/22/25: 325-119-2
What the firm is doing
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 recall@microbiologics.com. 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 recall@microbiologics.com. 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 recall@microbiologics.com with questions or concerns. Collect calls may be made.
DistributionShow detailsHide
Worldwide - US Nationwide.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0985-2026
- FDA 510(k) clearance · K861022The device's official FDA premarket clearance record
- FDA device classification · JTROfficial FDA classification for this device type
- CFR regulation · 21 CFR 866.2480The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Microbiologics IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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