Z-0788-2022Class III

LYFO Disk

Name: Z-0788-2022 LYFO Disk
Creator: Microbiologics Inc
Published: 2015-07-17
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2015-07-17 / Completed / root cause: labeling and UDI

FDA source

Microbiologics Inc began a recall of LYFO Disk on 2015-07-17. FDA classified it as Class III and gives the reason as "LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0788-2022
Classification: Class III
Status: Completed
Initiated: 2015-07-17
Posted: 2022-03-16
Recalling firm: Microbiologics, Inc.
Product: LYFO Disk
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Microbiologics notified customers on 07/17/2015 via letter titled "Medical Device Recall". Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall (LYFO DISK 0983L, Lot# 983-40-3), it is recommended that the customer destroys the product or return it to the recalling firm. Acknowledgement of the receipt of the recall letter was requested by completing a form and returning to Microbiologics. Questions or concerns can be directed to the Quality Systems Manager at 320.229.7050.
Quantity in commerce: 3 units
Distribution: Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Product codes and lots: Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0788-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0788-2022	Class III	Completed	Voluntary: Firm initiated	2022-03-23	2022-03-16

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)