CLASS III Device recall · Reported 23 Mar 2022 · FDA Enforcement Report

LYFO Disk recalled by Microbiologics

Microbiologics is recalling LYFO Disk, distributed nationwide in the US. The recall was initiated on 17 Jul 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesCatalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Quantity recalled3 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-0788-2022
FDA event ID: 89513
Recalling firm: Microbiologics, Saint Cloud, MN
Classification: Class III
Status: Completed
Recall initiated: 17 Jul 2015
FDA classified: 16 Mar 2022
Reported: 23 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Bacterial Contamination
Device type: Other Medical Devices

Timeline

17 Jul 2015	Recall initiated by company
16 Mar 2022	Classified by FDA	+2434 days
23 Mar 2022	Published in enforcement report	+7 days

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

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.

Product as listed by the FDA

LYFO Disk

Where it was distributed

Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

Nationwide Colorado Georgia Ohio

Questions about this recall

Why was it recalled?

Which lots are affected?

Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Where was it sold?

Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Microbiologics

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Reported	Class	Recall	Company	Reason	Where
31 Dec 2025Device	CLASS II	Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
31 Dec 2025Device	CLASS II	Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics	Microbiologics	Other Bacterial Contamination	Nationwide
10 Dec 2025Device	CLASS II	Kwik-stik, Quality control kit for culture media recalled	Microbiologics	Packaging Defects	MN
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