Device product
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Z-1400-2017
Product summary
- Firm
- Remel Inc
- Event
- Event 76445
- Status
- Terminated
- Classification
- Class II
- Quantity
- RO4033 - 163, R01503 - 50.
- Official record key
device-enforcement:Z-1400-2017
Official wording
Reason: Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
Code information: A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30
Distribution pattern: USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.
Derived failure modes
-
Unknown
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.