ClearanceBrief
Recall Z-0209-2018 ยท JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

Remel Inc

CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.

DateNov 2, 2017
StatusTerminated
ReasonProduct may have incorrect cation information detailed on the product label.
Root causeUnder Investigation by firm
ActionThe recalling firm issued letters dated 11/2/2017 via regular mail on 11/2/2017 notifying the customer of the incorrect labeling information and providing them the correct labeling information.
Quantity7 units
DistributionDistribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K802498MUELLER HINTON AGAR
Oxoid U.S.A., Inc., Nov 12, 1980