MicroScan Synergies Plus Negative Panels, 20 panels per box Medical device designed for use in determining quantitative
FDA device recall Z-0541-2009 · posted 2009-02-04 · Terminated
Recall details
- Recalling firm
- Siemens Microscan
- Reason for recall
- Falsely lowered imipenem MICs may result, leading to major errors in results.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- Total of both Negative and Synergy: 569,375 boxes
- Distribution
- Worldwide
- Date initiated
- 2008-07-31
- Date posted
- 2009-02-04
- Date terminated
- 2010-11-29
- Location
- West Sacramento, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (K870074) | Microscan Div. Baxter Healthcare Corp. | 1987-04-14 |