Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use
FDA device recall Z-2117-2010 · posted 2010-08-02 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin.
- Action taken
- Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 5544 bags
- Distribution
- Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand.
- Date initiated
- 2010-03-15
- Date posted
- 2010-08-02
- Date terminated
- 2010-08-03
- 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 |