Roche cobas p 512 Pre-analytical System Recalled for Sample Spillage
Roche is recalling 35 cobas p 512 pre-analytical systems because a sensor defect causes open sample tubes to drop and spill.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves sample spillage and equipment malfunction, but the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 35 units of the cobas p 512 pre-analytical system. This device is used for pre-analytical sample handling, including de-capping, aliquoting, and sorting of samples for analysis. The recall involves part numbers 05083435001 and 06268854001.
The recall is due to a false triggering or detection of the lifting gripper READY signal. This defect prevents sample tubes from being correctly placed back in the Rack Tube Transport (RTT) after the decapping process. As a result, open sample tubes can be dropped inside the cobas p 512, causing the sample material to spill.
The affected units were distributed in the United States, including Puerto Rico, and to the states of Texas, Ohio, Tennessee, Arizona, Washington, Michigan, and Georgia. Users of the cobas p 512 system should contact Roche Diagnostics Operations, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part numbers:05083435001 and 06268854001
Distribution
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