FDA Device recall Z-1200-2025
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
- FDA Device
- Class II
- ongoing
- Published 2025-02-26
On 2025-02-26 the FDA classified a Class II recall of remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use by Remel, citing product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood s….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1200-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-13 |
| Published | 2025-02-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Remel |
| Distribution | US |
Product
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Reason
Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
Identifiers
| code_info | UDI/DI 848838003691, Lot Number 213926, exp. 2025-02-24 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1200-2025%22
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