Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0788-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

LYFO Disk

Product Classification:

Class III

Date Initiated: July 17, 2015

Date Posted: March 23, 2022

Recall Number: Z-0788-2022

Event ID: 89513

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.

Status: Completed

Product Quantity: 3 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated