Recall Z-0788-2022
Microbiologics Inc · initiated July 17, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
LYFO Disk
Codes / lots: Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)
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.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0788-2022
- Initiated
- July 17, 2015
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 3 units
- Distribution
- Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN