LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Check against the official notice below — it lists the full affected range.
Microbiologics Inc. is recalling LYFO-DISK Enterococcus faecalis control microorganisms (Catalog Number 0959L) because the products tested as incorrectly susceptible to gentamicin. Specifically, the High Level Gentamicin Synergy value was outside specification when analyzed on the Vitek 2 AST-GP67 card, and the affected lots failed the disk diffusion method used for product release. The recall affects 183 units distributed worldwide, including throughout the United States and its territories, as well as numerous countries in Europe, Asia, South America, Africa, and the Middle East.
The affected lots are: 959-94-1 and 959-94-4 (both expiring 04/30/2020), 959-95-3 (expiring 09/30/2020), 959-96-2 (expiring 12/31/2020), and 959-97-3 (expiring 03/31/2021), identified by UDI 10845357023237. The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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, Quantity: 183 units Lot/code info: 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).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.