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Recall Observatory FDA recall evidence

Device product

LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299

Z-0713-2022

October 06, 2014

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 89451
Status
Terminated
Classification
Class II
Quantity
153 units
Official record key
device-enforcement:Z-0713-2022

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: Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-74-5 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-5 (04/22/2015), 959-75-11 (04/22/2015), and 959-77-2 (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

    reason.no_named_rule · v1.0.0

    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.