FDA Device recall Z-0713-2022
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299 by Microbiologics, citing this strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house tes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0713-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
Reason
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Identifiers
| code_info | Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-74-5 (10/08/2014), 959-74-8 (10/08/2014),…Catalog Number 0959L, UDI: 10845357023237, Lot Number (Expiration Date): 959-74-5 (10/08/2014), 959-74-8 (10/08/2014), 959-75-1 (04/22/2015), 959-75-5 (04/22/2015), 959-75-11 (04/22/2015), and 959-77-2 (10/21/2015) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0713-2022%22
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