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Recall Observatory FDA recall evidence

Device product

Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,

Z-1400-2017

February 09, 2017

Class II

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

    reason.no_named_rule · v1.0.0

    Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.