FDA recall Z-2531-2023

Remel, Inc · Class II · device

Product

remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora

Reason for recall

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

Distribution

US Nationwide Distribution

Key facts

Status
Ongoing
Initiation date
2023-08-14
Report date
2023-09-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2023