Microbiologics Inc Recall 89401
Description: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
Microbiologics Inc Recall 89401 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0586-2022 |
| Event ID | 89401 |
| Event Description | LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms |
| Product Type | Devices |
| 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. |
| Quantity | 1,726 units |
| Recall 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. |
| Device Classification | 20220216 |
| Device Code Info | Shared Lot Number (Expiration Date) with Product 1: 959-92-1 (10/31/2019), 959-92-2 (10/31/2019), 959-92-3 (10/31/2019), 959-92-4 (10/31/2019), 959-92-5 (10/31/2019), 959-92-6 (10/31/2019), 959-93-1 (02/29/2020), 959-93-2 (02/29/2020), 959-93-3 (02/29/2020), 959-93-4 (02/29/2020), 959-93-5 (02/29/2020), 959-93-6 (02/29/2020), 959-93-7 (02/29/2020). 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). |
| Center Classification Date | 20220208 |
| Recall Initiation Date | 20200218 |
| Recalling Firm | Microbiologics Inc |
| Initial Notification | Letter |
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