FDAFDA · Food and drugs·Recall number Z-1400-2017
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
Published March 15, 2017 · Recall initiated: February 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- 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.
- Lot
- A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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