FDA-Device2023-09-20Class II
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Remel, Inc
Hazard
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
Sold states
US Nationwide Distribution
Affected count
139 units (13,900 tests)
Manufactured in
12076 Santa Fe Trail Dr, Lenexa, KS, United States
Products
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2531-2023Don't want to check this manually?
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