Culture Media, Antimicrobial Susceptibility Test
Microbiology · 21 CFR 866.1700
Recent MDR events
1 adverse event reports on file
Recalls
5 recall events for this product code
- Diagnostic Hybrids IncTerminatedFeb 7, 2013
Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as
RhMK product fungal contamination.
Z-0792-2013 · View FDA record ↗ - Becton Dickinson & Co.TerminatedFeb 27, 2012
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on
Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..
Z-1107-2012 · View FDA record ↗ - Becton Dickinson & Co.TerminatedFeb 27, 2012
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on
Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..
Z-1108-2012 · View FDA record ↗ - Becton Dickinson & Co.TerminatedFeb 27, 2012
BBL[TM] Lysine Iron Agar, catalog #211363,500 g bottle 2014-03-31. Lysine Iron Agar was developed for use in the differentiation of enteric organisms based on
Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product..
Z-1109-2012 · View FDA record ↗ - Remel IncTerminatedUnknown
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Z-1400-2017 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
5 clearances for this product code
- I.A.F. Production, Inc.Aug 11, 1987
K872687 · IAFP MUELLER HINTON AGAR W/HEMO. W/CVA ENRICHMENT
- I.A.F. Production, Inc.Aug 11, 1987
K872688 · IAFP MUELLER HINTON AGAR W/5% SHEEP BLOOD
- I.A.F. Production, Inc.Aug 11, 1987
K872686 · IAFP MUELLER HINTON AGAR
- Acumedia Manufacturers, Inc.Oct 27, 1983
K833218 · YEAST BEEF AGAR-ANTIBIOTIC MED.4
- Acumedia Manufacturers, Inc.Oct 27, 1983
K833207 · AK AGAR 2