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 1,873 units of KWIK-STIK quality control kits containing Enterococcus faecalis across multiple countries worldwide, including the United States. The kits were sold as either a 2-pack (Catalog Number 0959P) or a 6-pack (Catalog Number 0959K). Specific affected lot numbers with expiration dates ranging from October 2014 to October 2015 are identified in the recall notice.
The recall was initiated because a specific lot of the bacterial strain was found to be susceptible to Gentamicin Synergy during in-house testing, when the strain should have been resistant to both high levels of Gentamicin and to Gentamicin Synergy. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Reason for recall: This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing. Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia/Hrvatska, Ecuador, Finland, France, Germany, Guam, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Kenya, Republic of Korea, Latvia, Macedonia, Malaysia, Netherlands, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, South Africa, Quantity: 1,873 units Lot/code info: a. Catalog Number 0959P, UDI: 20845357023210, Lot Number (Expiration Date): 959-74-2 (10/08/2014), 959-74-3 (10/08/2014), 959-74-7 (10/08/2014), 959-75-4 (04/22/2015), 959-75-8 (04/22/2015), 959-75-9 (04/22/2015), 959-75-14 (04/22/2015), 959-76-1 (07/08/2015), 959-77-3 (10/21/2015); b. Catalog Number 0959K, UDI: 30845357023224, Lot Number (Expiration Date): 959-74-4 (10/08/2014), 959-74-6 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-8 (04/22/2015), 959-75-12 (04/22/2015), and 959-77-1 (10/21/2015)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.