Recall Z-1391-2012 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc.
EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 through 4 used with the Dimension Vista(R) System. The EasyLink(TM) Informatics System is classified as a data calculator and processing module for use with In-vitro diagnostics devices. The EasyLink(TM) is included with the Dimension Vista(R) System, and may be used with other Siemens analyzers, as a c
| Date | Apr 10, 2012 (initiated Dec 2, 2011) |
| Status | Terminated |
| Reason | QC results may be unexpectedly associated with a Pending Control. When this situation occurs, Pending QC Controls maybe be created or reused. |
| Root cause | Device Design |
| Action | Siemens Healthcare Diagnostic Inc, sent a Urgent Field Safety Notice dated December 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were asked to follow these instructions. The first option is Extending the "Minimum Inactive Days" to 999 days. The second option is to proactively monitor the system for unexpected Pending QC Controls. Long Term Action Plan: A corrective and preventive action (CAPA) investigation has been issued. Currently firm is actively investigating. Further questions please |
| Quantity | 787 |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of CANADA, FRANCE, GERMANY, SPAIN, PORTUGAL, ITALY, JAPAN, NORWAY, AUSTRALIA, AUSTRIA, NEW ZEALAND, BELGIUM, SWITZERLAND, NETHERLANDS, MALAYASIA, SLOVENIA, SOUTH KOREA, DENMARK, SAUDI ARABIA, SLOVAKIA, PUERTO RICO, INDONESIA and TAIWAN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.