Dimension Vista V-LYTE Fluids: Diluent catalog number K835
FDA device recall Z-1039-2010 · posted 2010-03-10 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Results can elevate after sensor replacement. Sodium urine results can be falsely elevated 15 mmol/L within 24 hours after installation of a new sensor.
- Action taken
- The recalling firm issued an Urgent Field Safety Notice dated October 2009 to all affected customers. Customers were given instruction which minimize urine specimen use and report urine specimen results when QC is acceptable. Sensors are to be replaced when urine QC is out. Replacement sensors are available by contacting the firm at 800-241-0420. Please contact the Siemens Technical Solutions Center at 800-441-9250 for further assistance.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 150 units
- Distribution
- The product was shipped to medical facilities nationwide. The product was also shipped to Australia, Canada, Belgium, France, Germany, Italy, Japan, Malaysia, New Zealand, Netherlands, Portugal, Spain
- Date initiated
- 2009-10-22
- Date posted
- 2010-03-10
- Date terminated
- 2010-12-16
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA INTEGRATED SYSTEM (K051087) | Dade Behring, Inc. | 2005-07-11 |