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Recall Observatory FDA recall evidence

Device product

LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms

Z-0586-2022

February 18, 2020

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 89401
Status
Terminated
Classification
Class II
Quantity
183 units
Official record key
device-enforcement:Z-0586-2022

Official wording

Reason: Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Code information: Specific codes for Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-94-1 (04/30/2020), 959-94-4 (04/30/2020), 959-95-3 (09/30/2020), 959-96-2 (12/31/2020), 959-97-3 (03/31/2021).

Distribution pattern: Worldwide Distribution. US nationwide including Puerto Rico and Guam, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Curacao, Denmark, Ecuador, Egypt, El Salvador, Finland, France, Germany, Guatemala, Hong Kong, India, Ireland, Israel, Italy, Japan, Democratic People's Republic of Korea, Republic of Korea, Kuwait, Lebanon, Malaysia, Netherlands, New Zealand, Panama, Peru, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification