Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0585-2022)

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:

KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2-pack Enterococcus faecalis derived from ATCC 51299 b. KWIK-STIK 6-pack Enterococcus faecalis derived from ATCC 51299

Product Classification:

Class II

Date Initiated: February 18, 2020

Date Posted: February 16, 2022

Recall Number: Z-0585-2022

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: 1,975 units

Code Information:

a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-94-3 (04/30/2020), 959-95-2 (09/30/2020), 959-96-1 (12/31/2020), 959-96-4 (12/31/2021), 959-97-4 (03/31/2021), 959-97-5 (03/31/2021); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-94-2 (04/30/2020), 959-95-1 (09/30/2020), 959-95-5 (09/30/2020), 959-96-3 (12/31/2020), 959-97-1 (03/31/2021), 959-97-6 (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