cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Reported: March 30, 2016 Initiated: February 23, 2016 #Z-1233-2016
Product Description
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
Reason for Recall
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.
Details
- Recalling Firm
- Roche Diagnostics Operations, Inc.
- Units Affected
- 35 Units
- Distribution
- US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.. Recalled by Roche Diagnostics Operations, Inc.. Units affected: 35 Units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 30, 2016. Severity: Moderate. Recall number: Z-1233-2016.
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