LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Reported: February 16, 2022 Initiated: February 18, 2020 #Z-0586-2022
Product Description
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Reason for Recall
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.
Details
- Recalling Firm
- Microbiologics Inc
- Units Affected
- 183 units
- Distribution
- 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.
- Location
- Saint Cloud, MN
Frequently Asked Questions
What product was recalled? ▼
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms. Recalled by Microbiologics Inc. Units affected: 183 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Moderate. Recall number: Z-0586-2022.
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