FDAFDA · Food and drugs·Recall number Z-2305-2012
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.
Published September 12, 2012 · Recall initiated: May 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Distributor
- USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.
- Lot
- Version VA11B and all previously released versions.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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