—#153231

Product

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

FDA product code: LKA — Culture Media, Antimicrobial Susceptibility Test
Device class: Class 2
Medical specialty: Microbiology
Affected lot / code info: A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm. If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International) For further questions, please call (913) 895-4077.

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

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.

Timeline

Recall initiated: 2017-02-09
Terminated: 2019-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153231. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.