LYFO DISK recallZ-0788-2022 · Microbiologics Inc · initiated Jul 17, 2015
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Microbiologics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0788-2022
- Status
- Completed
- Initiated by the company
- Jul 17, 2015
- Recalling firm
- Microbiologics Inc
- Quantity
- 3 units
- Product code
- JTR
- FDA submissions
- K861022
- Distribution
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Product description
LYFO Disk
Code information (models, lots, serial numbers)
Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LYFO DISK™ 0983LMicrobiologics Inc. · KIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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