Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0586-2022)

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 Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Product Classification:

Class II

Date Initiated: February 18, 2020

Date Posted: February 16, 2022

Recall Number: Z-0586-2022

Event ID: 89401

Reason for Recall:

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Status: Terminated

Product Quantity: 183 units

Code Information:

Specific codes for Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-94-1 (04/30/2020), 959-94-4 (04/30/2020), 959-95-3 (09/30/2020), 959-96-2 (12/31/2020), 959-97-3 (03/31/2021).

Distribution Pattern:

Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated