Z-0713-2022Class II

LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC...

Name: Z-0713-2022 LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC...
Creator: Microbiologics Inc
Published: 2014-10-06
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2014-10-06 / Terminated / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 on 2014-10-06. FDA classified it as Class II and gives the reason as "This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0713-2022
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2022-03-03
Terminated: 2023-01-17
Recalling firm: Microbiologics, Inc.
Product: LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Product code: JTR Kit, Quality Control For Culture Media
Reason for recall: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Microbiologics notified customers on about 10/06/2014 via letter titled "E.faecalis Gentamicin Susceptibility Notification." Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected. Questions or concerns can be directed to the Technical Support team at 320.229.7064 or [email protected].
Quantity in commerce: 153 units
Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
Product codes and lots: Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-74-5 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-5 (04/22/2015), 959-75-11 (04/22/2015), and 959-77-2 (10/21/2015)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0713-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0712-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-03
Z-0713-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-03
Z-0714-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-09	2022-03-03

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)