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

Recall date

February 9, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1400-2017

FDA classification

Class II

Brand / firm

Remel Inc

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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