Recall Z-0541-2009 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Siemens Microscan
MicroScan Synergies Plus Negative 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 Nos. B1016-200, B1016-201, B1016-202, B1016-203, B1025-103, B
| 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
| K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS Microscan Div. Baxter Healthcare Corp., Apr 14, 1987 |