FDA Device recall Z-0801-2013
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionell…
- FDA Device
- Class II
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class II recall of The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionell… by Remel, citing the product may contain low level microbial contamination which could result in incorrect results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0801-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-10-10 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | IL, IN, MI |
Product
The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
Reason
The product may contain low level microbial contamination which could result in incorrect results.
Identifiers
| code_info | Lot 1175209 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0801-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.