Reported Mar 30, 2016 · Terminated
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of…
Roche Diagnostics Operations, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Operations, Inc. · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
- cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
- Lot codes and dates
- Part numbers05083435001 and 06268854001
- Amount recalled
- 35 Units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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