[Recalled] LYFO Disk — LYFO Disk Catalog #0983L is to contain Candida tropicalis | FDA 2015-07-17
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | LYFO Disk |
|---|---|
| Brand / manufacturer | Microbiologics Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0788-2022 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 17 July 2015 |
| EAN / barcode | 10845357023930 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class III recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Microbiologics Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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