Device product
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
Z-0712-2022
Product summary
- Event
- Event 89451
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,873 units
- Official record key
device-enforcement:Z-0712-2022
Official wording
Reason: 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.
Code information: 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)
Distribution pattern: 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, Switzerland, Taiwan, Tanzania, Thailand, Turkey, Uganda, United Arab Emirates, and Vietnam.
Derived failure modes
-
Unknown
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.