FDAFDA · Food and drugs·Recall number Z-1233-2016
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Published March 30, 2016 · Recall initiated: February 23, 2016
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
Due to a false triggering or detection of the lifting gripper READY signal, sample tubes are not correctly placed back in the Rack Tube Transport (RTT) after the decapping process. Therefore, open sample tubes can be dropped in the cobas p 512, spilling the sample material.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Distributor
- US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
- Lot
- Part numbers:05083435001 and 06268854001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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