Z-0586-2022 Class II Terminated
FDA device recall Z-0586-2022 was initiated by Microbiologics Inc on February 18, 2020 and is designated Class II. 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 diff… The recall status is terminated (terminated July 11, 2022). Affected quantity: 183 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 16, 2022
- Initiation Date
- February 18, 2020
- Termination Date
- July 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 183 units
Product Description
Reason for Recall
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.