CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report

Lyfo-disk, Quality control kit for culture media, sold as recalled

Microbiologics is recalling Lyfo-disk, Quality control kit for culture media, sold as: Lyfo-disk Enterococcus, distributed nationwide in the US. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog 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)

Quantity recalled153 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0713-2022
FDA event ID: 89451
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2014
FDA classified: 3 Mar 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Oct 2014	Recall initiated by company
3 Mar 2022	Classified by FDA	+2705 days
9 Mar 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is Lyfo-disk, Quality control kit for culture media, sold as: Lyfo-disk Enterococcus recalled?

Yes. Microbiologics recalled Lyfo-disk, Quality control kit for culture media, sold as: Lyfo-disk Enterococcus on 6 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0713-2022.

Why was it recalled?

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.

Which lots are affected?

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)

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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