Recall Z-1525-2013 ยท LTT Panels, Test, Susceptibility, Antimicrobial
Siemens Healthcare Diagnostics, Inc.
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), For use in determining quantitative and/or qualitative antimicrobial agent susceptibility.
| Date | Jun 8, 2013 (initiated May 2, 2013) |
| Status | Terminated |
| Reason | The product has the potential for false negative or delayed reaction for Arginine (ARG) results. In addition, 42 hour identification panel holds may occur due to a weak ARG reaction. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent an Urgent Field Safety Notice dated May 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact your local Siemens Healthcare Diagnostics Representative for information concerning this notice. |
| Quantity | 683 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.