FDAFDA · Food and drugs·Recall number Z-0714-2022
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Published March 9, 2022 · Recall initiated: October 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Microbiologics Inc
- Distributor
- 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.
- Lot
- Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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