Remel Inc: Medical Device Recall in 2017 - (Recall #: Z-1400-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 9, 2017

Date Posted: March 15, 2017

Recall Number: Z-1400-2017

Event ID: 76445

Reason for Recall:

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

Status: Terminated

Product Quantity: RO4033 - 163, R01503 - 50.

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.

Voluntary or Mandated:

Voluntary: Firm initiated