LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro… — Class II medical device recall Z-0586-2022
Terminated recall by Microbiologics Inc, reported 2022-02-16, distributed nationwide. Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (s
| Recall number | Z-0586-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2020-02-18 |
| Classified | 2022-02-08 |
| Reported by FDA | 2022-02-16 |
| Terminated | 2022-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CW, DE, DK, EC, EG, ES, FI, FR, GB, GT, HK, HR, IE, IL, IN, IT, JP, KR, KW, LB, MY, NL, NZ, PA, PE, PL, PT, QA, RO, SA, SE, SG, SV, TH, TR, TT, TW, VN, ZA |
| Quantity | 183 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10845357023237 |
| Lot numbers | 959-94-1, 959-94-4, 959-95-3, 959-96-2, 959-97-3 |
| Model numbers | 0959L |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0586-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.