FDA Device recall Z-0583-2022
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable…
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable… by Microbiologics, citing potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0583-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-01 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49619(TM). LYFO DISK microorganisms are packaged in a resealable vial that contains 6 lyophilized microorganism pellets and a desiccant to prevent adverse moisture accumulation. The LYFO DISK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements.
Reason
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
Identifiers
| code_info | Catalog Number: 0947L, Lot Number: 947-126-1, UDI: 10845357022964 |
|---|
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-0583-2022%22
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