Z-0986-2026Class II

LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L

Name: Z-0986-2026 LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Creator: Microbiologics Inc
Published: 2025-12-02
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2025-12-02 / Open, Classified

FDA source

Microbiologics Inc began a recall of LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L on 2025-12-02. FDA classified it as Class II and gives the reason as "Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0986-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-02
Posted: 2025-12-22
Recalling firm: Microbiologics, Inc.
Product: LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 1 unit (16 additional units added 12/22/25)
Distribution: Worldwide - US Nationwide.
Product codes and lots: UDI-DI: 10845357006476; Lot Numbers: 325-120-5, Additional lots added 12/22/25: 325-119-3, 325-119-6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0986-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0984-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0985-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22
Z-0986-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-22

Product code JTR

K861022Class IKwik Stik(tm) Lyfo(tm) Disk MicroorganismsMicro-Bio-Logics / cleared 1986-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)