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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2531-2023%22
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