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
Check against the official notice below — it lists the full affected range.
Microbiologics Inc is recalling 1,975 units of KWIK-STIK quality control kits for culture media in two formats: a 2-pack and 6-pack containing Enterococcus faecalis. The kits were distributed worldwide to numerous countries including the United States, Puerto Rico, Guam, and Australia. The recall affects specific lot numbers of Catalog Numbers 0959P and 0959K with expiration dates ranging from April 2020 through March 2021.
The kits are being recalled because they returned incorrect susceptible test results when analyzed on Vitek 2 AST-GP67 cards, with High Level Gentamicin Synergy values falling outside acceptable specifications. These same lots failed the disk diffusion method used for product release testing. The source document does not specify what actions affected consumers should take in response to 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: 1,975 units Lot/code info: 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);
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.