Recall Z-0980-2010 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
Dimension Vista LOCI Reaction Vessel
| Date | Mar 5, 2010 (initiated Nov 24, 2009) |
| Status | Terminated |
| Reason | Some vessels may leak. If leakage occurs, patient results will be flagged and are not reportable. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued an Urgent Field Safety Notice dated 11/2009 to all affected customers. Customers have been told to discard any bags of the affected lot. If the affected lot is the only lot the customer has, customers can examine a vessel from the bag. If the vessel mold cavity identity is B8, customers should discard the bag. Thus customers can use the lot if the cavity mold is anything other than B8. In addition, customers have been told to empty the LOCI vessel holder on all systems and to discard vessels in case any affected vessels have been loaded onto the system. For technical |
| Quantity | 408 units |
| Distribution | The device was shipped to medical facilities in CA, CO, FL, GA, IL, LA, MD, MI, MS, NE, NC, NJ, NY, OH, SC, TN, TX, VA, WA, and WI. The product was also shipped to Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051087 | DIMENSION VISTA INTEGRATED SYSTEM Dade Behring, Inc., Jul 11, 2005 |