Recall Z-2599-2018 ยท LTT Panels, Test, Susceptibility, Antimicrobial
Beckman Coulter Inc.
MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determining antimicrobial agent susceptibility and/or identification to the species level of rapidly growing aerobic and facultative gram-positive cocci, some fastidious aerobic gram-positive cocci and Listeria monocytogenes.
| Date | May 4, 2018 |
| Status | Terminated |
| Reason | The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incorrect MIC results for Mxf could be reported. |
| Root cause | Labeling design |
| Action | A recall notification letter was sent the week of 05/01/2018 via email, mail, and phone if needed. |
| Quantity | 686 boxes |
| Distribution | NJ, TX, IA, PA, FL, NE, OH, NY, CA, MO, OK, LA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020160 | DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN Dade Behring, Inc., Mar 14, 2002 |