Z-0788-2022 Class III
FDA device recall Z-0788-2022 was initiated by Microbiologics Inc on Jul 17, 2015 and is designated Class III. 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… Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 23, 2022
- Initiation Date
- Jul 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
LYFO Disk
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.
Distribution Pattern
Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
Code Information
Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0788-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026