Recall Z-1400-2017 ยท LKA Culture Media, Antimicrobial Susceptibility Test
Remel Inc
Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
| Date | Feb 9, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 cont |
| Quantity | RO4033 - 163, R01503 - 50. |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.