Home › Device types › LKA
Culture Media, Antimicrobial Susceptibility Test
FDA product code LKA · Class 2 · Microbiology
0
Registered devices
1
Adverse events
5
Recalls
5
510(k) clearances
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-02-09 | Remel Inc | Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests. |
| 2012-12-31 | Diagnostic Hybrids Inc | RhMK product fungal contamination. |
| 2012-01-11 | Becton Dickinson & Co. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
| 2012-01-11 | Becton Dickinson & Co. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
| 2012-01-11 | Becton Dickinson & Co. | Lysine Iron Agar may not produce the correct biochemical reactions with Quality Control organisms over the shelf life of the product.. |
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