FDA Device recall Z-2531-2023
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of remel TODD HEWITT W. CNA (LIM BROTH), REF R064810 by Remel, citing on lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2531-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-14 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Remel |
| Distribution | US |
Product
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Reason
On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
Identifiers
| code_info | UDI/DI 00848838010064, lot 668255, Exp. 04/26/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Remel
- GC Agar Base (150mm) 10/PK R04030
FDA Device · Class II · 2026-07-08 · Remel - Yeastone Broth, 11ML, 10/BOX YY3462
FDA Device · Class II · 2026-04-22 · Remel - Campy CVA Medium 100/PK, R01272
FDA Device · Class II · 2026-03-04 · Remel - 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Device · Class II · 2025-12-03 · Remel - Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Device · Class II · 2025-08-06 · Remel
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2531-2023%22
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