Recall Z-0540-2009 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Siemens Microscan
MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels, 20 panels per box. Medical device designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification to the species level of colonies, grown on solid media, of rapidly growing aerobic and facultative anaerobic gram-negative bacteria. Catalog numbers B1016-100, B1016-101,
| Date | Feb 4, 2009 (initiated Jul 31, 2008) |
| Status | Terminated |
| Reason | Falsely lowered imipenem MICs may result, leading to major errors in results. |
| Root cause | Other |
| Action | Consignees were notified on July 31, 2008 by letter (Urgent Device Correction) sent via FedEx overnight. International consignees were notified by Siemens Healthcare Diagnostics associates in affected countries. The letter described the problem and provided users with safety instructions to follow until an update is provided. Contact Siemens Healthcare Diagnostics Inc. at 916-374-3075 for additional assistance. |
| Quantity | Total of both Negative and Synergy: 569,375 boxes |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020246 | MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) Dade Behring, Inc., Feb 6, 2002 |