LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
FDA Recall Z-0713-2022 · Posted None
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Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2014-10-06
Date Terminated2023-01-17
Product Quantity153 units
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.
Firm Action
Microbiologics notified customers on about 10/06/2014 via letter titled "E.faecalis Gentamicin Susceptibility Notification." Instructions included to inspect inventory for affected products. If customers have received the product identified within the recall, it is recommended that the intended use of the organism be reviewed to determine if Gentamicin synergy results have an impact on use. It is recommended to discard these lots if an impact is to be expected.
Questions or concerns can be directed to the Technical Support team at 320.229.7064 or [email protected].
Root Cause
Nonconforming Material/Component
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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